|
1
|
Randel KR, Botteri E, de Lange T, Schult AL, Eskeland SL, El‐Safadi B, Norvard ER, Bolstad N, Bretthauer M, Hoff G, Holme Ø. Performance of Faecal Immunochemical Testing for Colorectal Cancer Screening at Varying Positivity Thresholds. Aliment Pharmacol Ther 2025; 61:122-131. [PMID: 39373173 PMCID: PMC11636076 DOI: 10.1111/apt.18314] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/07/2024] [Revised: 04/07/2024] [Accepted: 09/19/2024] [Indexed: 10/08/2024]
Abstract
BACKGROUND The positivity thresholds of faecal immunochemical testing (FIT) in colorectal cancer (CRC) screening vary between countries. AIMS To explore the trade-off between colonoscopies performed, adverse events and lesions detected at different FIT thresholds in a Norwegian CRC screening trial. METHODS We included first participation in biennial FIT screening for 47,265 individuals aged 50-74 years. Individuals with FIT > 15 μg Hb/g faeces were referred for colonoscopy. We estimated the number of colonoscopies, adverse events, screen-detected CRCs, advanced adenomas and serrated lesions expected at FIT thresholds currently or recently used in other European countries ranging between 20 and 150 μg/g. RESULTS At the 15 μg/g threshold (Norway), 3705 participants underwent colonoscopy, of whom 203 had CRC, 1119 advanced adenomas and 256 advanced serrated lesions. Using a 47 μg/g threshold, 1826 (49.3%) individuals would have undergone colonoscopy, and 154 (75.9%) would have been diagnosed with CRC, 702 (62.7%) with advanced adenoma and 128 (50.0%) with advanced serrated lesion compared to the 15 μg/g threshold. At 150 μg/g, the corresponding figures would have been 838 (22.6%) undergoing colonoscopy, 114 (56.2%) with CRC, 345 (30.8%) advanced adenoma and 54 (21.1%) advanced serrated lesions. The detection rate of stage I CRC was 0.22% at 15 μg/g and 0.11% at 150 μg/g. Post-colonoscopy bleeding rates were 0.8% and 1.7%, respectively. CONCLUSIONS Increasing the FIT threshold reduces colonoscopy demand, but substantially decreases lesion detection and unfavourably changes CRC stage distribution. The risk of adverse events at colonoscopy increased with FIT threshold, requiring country-specific information on adverse events. TRIAL REGISTRATION Clinicaltrials.gov identifier: NCT01538550.
Collapse
Affiliation(s)
- Kristin Ranheim Randel
- Department of Research and DevelopmentTelemark HospitalSkienNorway
- Institute of Health and SocietyUniversity of OsloOsloNorway
- Section for Colorectal Cancer Screening, Cancer Registry of NorwayNorwegian Institute of Public HealthOsloNorway
| | - Edoardo Botteri
- Section for Colorectal Cancer Screening, Cancer Registry of NorwayNorwegian Institute of Public HealthOsloNorway
- Department of Research, Cancer Registry of NorwayNorwegian Institute of Public HealthOsloNorway
| | - Thomas de Lange
- Department of MedicineSahlgrenska University Hospital‐MölndalRegion Västra GötalandSweden
- Department of Molecular and Clinical Medicine, Sahlgrenska AcademyUniversity of GothenburgGothenburgSweden
| | - Anna Lisa Schult
- Section for Colorectal Cancer Screening, Cancer Registry of NorwayNorwegian Institute of Public HealthOsloNorway
- Department of MedicineVestre Viken Hospital Trust BærumGjettumNorway
| | | | | | - Espen R. Norvard
- Department of PathologyVestre Viken Hospital Trust DrammenDrammenNorway
| | - Nils Bolstad
- Department of Medical BiochemistryOslo University HospitalOsloNorway
| | - Michael Bretthauer
- Department of Transplantation MedicineOslo University HospitalOsloNorway
- Clinical Effectiveness Research Group, Institute of Health and SocietyUniversity of OsloOsloNorway
| | - Geir Hoff
- Department of Research and DevelopmentTelemark HospitalSkienNorway
- Section for Colorectal Cancer Screening, Cancer Registry of NorwayNorwegian Institute of Public HealthOsloNorway
| | - Øyvind Holme
- Institute of Health and SocietyUniversity of OsloOsloNorway
- Department of MedicineSørlandet Hospital KristiansandKristiansandNorway
| |
Collapse
|
|
2
|
Gao Y, Xin L, Lin H, Yao B, Zhang T, Zhou AJ, Huang S, Wang JH, Feng YD, Yao SH, Guo Y, Dang T, Meng XM, Yang ZZ, Jia WQ, Pang HF, Tian XJ, Deng B, Wang JP, Fan WC, Wang J, Shi LH, Yang GY, Sun C, Wang W, Zang JC, Li SY, Shi RH, Li ZS, Wang LW. Machine learning-based automated sponge cytology for screening of oesophageal squamous cell carcinoma and adenocarcinoma of the oesophagogastric junction: a nationwide, multicohort, prospective study. Lancet Gastroenterol Hepatol 2023; 8:432-445. [PMID: 36931287 DOI: 10.1016/s2468-1253(23)00004-3] [Citation(s) in RCA: 21] [Impact Index Per Article: 10.5] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/14/2022] [Revised: 01/10/2023] [Accepted: 01/11/2023] [Indexed: 03/16/2023]
Abstract
BACKGROUND Oesophageal squamous cell carcinoma and adenocarcinoma of the oesophagogastric junction have a dismal prognosis, and early detection is key to reduce mortality. However, early detection depends on upper gastrointestinal endoscopy, which is not feasible to implement at a population level. We aimed to develop and validate a fully automated machine learning-based prediction tool integrating a minimally invasive sponge cytology test and epidemiological risk factors for screening of oesophageal squamous cell carcinoma and adenocarcinoma of the oesophagogastric junction before endoscopy. METHODS For this multicohort prospective study, we enrolled participants aged 40-75 years undergoing upper gastrointestinal endoscopy screening at 39 tertiary or secondary hospitals in China for model training and testing, and included community-based screening participants for further validation. All participants underwent questionnaire surveys, sponge cytology testing, and endoscopy in a sequential manner. We trained machine learning models to predict a composite outcome of high-grade lesions, defined as histology-confirmed high-grade intraepithelial neoplasia and carcinoma of the oesophagus and oesophagogastric junction. The predictive features included 105 cytological and 15 epidemiological features. Model performance was primarily measured with the area under the receiver operating characteristic curve (AUROC) and average precision. The performance measures for cytologists with AI assistance was also assessed. FINDINGS Between Jan 1, 2021, and June 30, 2022, 17 498 eligible participants were involved in model training and validation. In the testing set, the AUROC of the final model was 0·960 (95% CI 0·937 to 0·977) and the average precision was 0·482 (0·470 to 0·494). The model achieved similar performance to consensus of cytologists with AI assistance (AUROC 0·955 [95% CI 0·933 to 0·975]; p=0·749; difference 0·005, 95% CI, -0·011 to 0·020). If the model-defined moderate-risk and high-risk groups were referred for endoscopy, the sensitivity was 94·5% (95% CI 88·8 to 97·5), specificity was 91·9% (91·2 to 92·5), and the predictive positive value was 18·4% (15·6 to 21·6), and 90·3% of endoscopies could be avoided. Further validation in community-based screening showed that the AUROC of the model was 0·964 (95% CI 0·920 to 0·990), and 92·8% of endoscopies could be avoided after risk stratification. INTERPRETATION We developed a prediction tool with favourable performance for screening of oesophageal squamous cell carcinoma and adenocarcinoma of the oesophagogastric junction. This approach could prevent the need for endoscopy screening in many low-risk individuals and ensure resource optimisation by prioritising high-risk individuals. FUNDING Science and Technology Commission of Shanghai Municipality.
Collapse
Affiliation(s)
- Ye Gao
- Department of Gastroenterology, Changhai Hospital, Naval Medical University, Shanghai, China; National Clinical Research Center for Digestive Diseases (Shanghai), Shanghai, China
| | - Lei Xin
- Department of Gastroenterology, Changhai Hospital, Naval Medical University, Shanghai, China; National Clinical Research Center for Digestive Diseases (Shanghai), Shanghai, China
| | - Han Lin
- Department of Gastroenterology, Changhai Hospital, Naval Medical University, Shanghai, China; National Clinical Research Center for Digestive Diseases (Shanghai), Shanghai, China
| | - Bin Yao
- School of Computer Science and Engineering, Southeast University, Nanjing, Jiangsu Province, China
| | - Tao Zhang
- Department of Gastroenterology, Nanchong Central Hospital, Nanchong, Sichuan Province, China
| | - Ai-Jun Zhou
- Department of Gastroenterology, Lianshui People's Hospital Affiliated to Kangda College of Nanjing Medical University, Huai'an, Jiangsu Province, China
| | - Shu Huang
- Department of Gastroenterology, Lianshui People's Hospital Affiliated to Kangda College of Nanjing Medical University, Huai'an, Jiangsu Province, China
| | - Jian-Hua Wang
- Department of Gastroenterology, The First People's Hospital of Yancheng, Yancheng, Jiangsu Province, China
| | - Ya-Dong Feng
- Department of Gastroenterology, Zhongda Hospital, Southeast University, Nanjing, Jiangsu Province, China
| | - Sheng-Hua Yao
- Department of Gastroenterology, Yangzhong People's Hospital, Zhenjiang, Jiangsu Province, China
| | - Yan Guo
- Department of Gastroenterology, Yangzhong People's Hospital, Zhenjiang, Jiangsu Province, China
| | - Tong Dang
- Department of Digestive Diseases, Inner Mongolia Institute of Digestive Diseases, The Second Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology, Baotou, Inner Mongolia, China
| | - Xian-Mei Meng
- Department of Digestive Diseases, Inner Mongolia Institute of Digestive Diseases, The Second Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology, Baotou, Inner Mongolia, China
| | - Zeng-Zhou Yang
- Digestive Endoscopy Unit, Linzhou People's Hospital, Anyang, Henan Province, China
| | - Wan-Qi Jia
- Gastrointestinal Endoscopy Center, Nanyang Second People's Hospital, Nanyang, Henan Province, China
| | - Hui-Fang Pang
- Department of Gastroenterology, Digestive Endoscopy Unit, Tongliao City Hospital, Tongliao, Inner Mongolia, China
| | - Xiao-Juan Tian
- Department of Gastroenterology, Xixia County People's Hospital, Nanyang, Henan Province, China
| | - Bin Deng
- Department of Gastroenterology, Affiliated Hospital of Yangzhou University, Yangzhou, Jiangsu Province, China
| | - Jun-Ping Wang
- Department of Gastroenterology, Shanxi Provincial People's Hospital, Taiyuan, Shanxi Province, China
| | - Wen-Chuan Fan
- Department of Gastroenterology, Digestive Endoscopy Center, The People's Hospital of Yanting City, Mianyang, Sichuan Province, China
| | - Jun Wang
- Department of Gastroenterology, Jinhu County People's Hospital, Huaian, Jiangsu Province, China
| | - Li-Hong Shi
- Department of Gastroenterology, the Second Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jiangsu Province, China
| | - Guan-Yu Yang
- School of Computer Science and Engineering, Southeast University, Nanjing, Jiangsu Province, China
| | - Chang Sun
- Department of Gastroenterology, Changhai Hospital, Naval Medical University, Shanghai, China; National Clinical Research Center for Digestive Diseases (Shanghai), Shanghai, China
| | - Wei Wang
- Department of Gastroenterology, Changhai Hospital, Naval Medical University, Shanghai, China; National Clinical Research Center for Digestive Diseases (Shanghai), Shanghai, China
| | - Jun-Cai Zang
- Harbor Scientific Instrument, Xiangtan, Hunan, China
| | - Song-Yang Li
- Harbor Scientific Instrument, Xiangtan, Hunan, China
| | - Rui-Hua Shi
- Department of Gastroenterology, Zhongda Hospital, Southeast University, Nanjing, Jiangsu Province, China
| | - Zhao-Shen Li
- Department of Gastroenterology, Changhai Hospital, Naval Medical University, Shanghai, China; National Clinical Research Center for Digestive Diseases (Shanghai), Shanghai, China
| | - Luo-Wei Wang
- Department of Gastroenterology, Changhai Hospital, Naval Medical University, Shanghai, China; National Clinical Research Center for Digestive Diseases (Shanghai), Shanghai, China.
| |
Collapse
|
|
3
|
Ribe SG, Botteri E, Løberg M, Randel KR, Kalager M, Nilsen JA, Gulichsen EH, Holme Ø. Impact of time between faecal immunochemical tests in colorectal cancer screening on screening results: A natural experiment. Int J Cancer 2023; 152:1414-1424. [PMID: 36346118 PMCID: PMC10098820 DOI: 10.1002/ijc.34351] [Citation(s) in RCA: 7] [Impact Index Per Article: 3.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/10/2022] [Revised: 09/27/2022] [Accepted: 10/17/2022] [Indexed: 11/11/2022]
Abstract
Repeated rounds of faecal immunochemical testing (FIT) for occult blood is a common method for screening for colorectal cancer (CRC). However, the time interval between FIT rounds is not thoroughly investigated. In a CRC screening trial in South-Eastern Norway, individuals were invited for biennial FIT between 2012 and 2019. The positivity threshold was >15 mcg haemoglobin/g faeces (mcg/g). Due to organizational challenges, the interval between screening rounds randomly varied between 1.5 and 3.5 years, forming a natural experiment. We investigated the detection rate of CRC and advanced neoplasia (AN: CRC or advanced adenoma) at the subsequent round (FIT2 ), according to the faecal haemoglobin concentration (f-Hb) at the initial screening round (FIT1 ), and time between the two screening rounds. 18 522 individuals with negative FIT1 who attended FIT2 were included in this study. 245 AN were detected at FIT2 , of which 34 were CRC. The CRC detection rate at FIT2 for participants with FIT1 = 0 mcg/g was 0.09% while it was 0.28% for participant with 0 > FIT1 ≤ 15 mcg/g; odds ratio (OR) 3.22, 95% CI 1.49-6.95. For each 3 months' increment between FITs, the OR for detecting CRC was 1.33 (95% CI 0.98-1.79), while the OR was 1.13 (1.02-1.26) for AN. Individuals with FIT1 -value of 0 mcg/g, had a lower AN detection rate compared with participants with 0 > FIT1 ≤ 15 mcg/g, irrespective of time between tests. Although CRC and AN detection rates increase with increasing time interval between FITs, individuals with undetectable f-Hb at first screen have substantially lower risk of CRC at the next screening round compared with individuals with detectable f-Hb.
Collapse
Affiliation(s)
- Sara G Ribe
- Section for Colorectal Cancer Screening, Cancer Registry of Norway, Oslo, Norway.,Center for Cancer Treatment, Sørlandet Hospital, Kristiansand, Norway.,Clinical Effectiveness Research Group, Institute for Health and Society, University of Oslo, Oslo, Norway
| | - Edoardo Botteri
- Section for Colorectal Cancer Screening, Cancer Registry of Norway, Oslo, Norway.,Clinical Effectiveness Research Group, Institute of Clinical Medicine, University of Oslo, Oslo, Norway
| | - Magnus Løberg
- Clinical Effectiveness Research Group, Institute for Health and Society, University of Oslo, Oslo, Norway.,Department of Research, Cancer Registry of Norway, Oslo, Norway
| | - Kristin R Randel
- Section for Colorectal Cancer Screening, Cancer Registry of Norway, Oslo, Norway
| | - Mette Kalager
- Clinical Effectiveness Research Group, Institute for Health and Society, University of Oslo, Oslo, Norway.,Clinical Effectiveness Research Group, Institute of Clinical Medicine, University of Oslo, Oslo, Norway
| | | | | | - Øyvind Holme
- Section for Colorectal Cancer Screening, Cancer Registry of Norway, Oslo, Norway.,Clinical Effectiveness Research Group, Institute for Health and Society, University of Oslo, Oslo, Norway.,Department of Medicine, Sørlandet Hospital, Kristiansand, Norway
| |
Collapse
|
|
4
|
Cama R, Kapoor N, Sawyer P, Patel B, Landy J. Evaluation of 13,466 Fecal Immunochemical Tests in Patients Attending Primary Care for High- and Low-Risk Gastrointestinal Symptoms of Colorectal Cancer. Dig Dis Sci 2022; 68:2023-2029. [PMID: 36357596 PMCID: PMC9649003 DOI: 10.1007/s10620-022-07754-8] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/30/2022] [Accepted: 10/26/2022] [Indexed: 11/12/2022]
Abstract
AIM/OBJECTIVE Quantitative fecal immunochemical tests (FIT) were recommended by NICE for patients in primary care presenting with low-risk symptoms of colorectal cancer (CRC). FIT is more accurate in the detection of CRC than symptom criteria. Despite this, CRC still occurs with a negative FIT and the importance of safety netting for patients with severe or persistent symptoms is paramount. We aimed to evaluate the utilization and accuracy of FIT for CRC in low and high-risk symptom groups presenting to primary care, the effectiveness of safety netting in primary care, referral practices with FIT utilization for symptomatic patients and the clinical features of FIT negative patients with CRC. MATERIALS AND METHODS Medical records and databases of all patients undertaking a FIT sample in the Herts Valleys CCG between June 2019 and November 2021 were reviewed. 13,466 consecutive FIT samples were requested for 12,231 patients between June 2019 and November 2021. RESULTS Analysis of diagnostic accuracy was undertaken for the first 5341 patients with a minimum of 12 months follow up. Sensitivity for CRC, in FIT ≥ 4 µg Hb/g, ≥ 10 µg Hb/g and ≥ 100 µg Hb/g was 93% (95% CI 85-98%), 91% (95% CI 82-96%) and 72% (95% CI 60-81%) with a number needed to investigate of 36, 19 and 6, respectively. CONCLUSION A FIT ≥ 10 µg Hb/g in conjunction with ongoing GP clinical concern within 8 weeks had a sensitivity for CRC of 97% (95% CI 90-100%), a PPV of 3.6% (95% CI 3.4-3.7%) and a number needed to investigate to detect one CRC of 28.
Collapse
Affiliation(s)
- Rigers Cama
- Gastroenterology Department, West Hertfordshire Hospitals NHS Trust, Watford, WD18 0HB UK
| | - Neel Kapoor
- Gastroenterology Department, West Hertfordshire Hospitals NHS Trust, Watford, WD18 0HB UK
| | - Philip Sawyer
- Parkbury House Surgery, Herts Valleys CCG, St Albans, AL1 3HD UK
| | - Bharat Patel
- Chemical Pathology Department, West Hertfordshire Hospitals NHS Trust, Watford, WD18 0HB UK
| | - Jonathan Landy
- Gastroenterology Department, West Hertfordshire Hospitals NHS Trust, Watford, WD18 0HB UK
| |
Collapse
|
|
5
|
Evaluation of a colorectal cancer screening program composed of successive waves of different tests: The experience of the French Calvados County. Cancer Epidemiol 2022; 80:102240. [PMID: 36058037 DOI: 10.1016/j.canep.2022.102240] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/31/2022] [Revised: 08/08/2022] [Accepted: 08/10/2022] [Indexed: 11/21/2022]
Abstract
BACKGROUNDS The value of colorectal cancer (CRC) screening program in a population with a limited participation rate is debated. This study assesses the real-life performances of different screening tests in a population benefiting from an organized program and included in a cancer registry. METHODS Patients who participated in at least one screening campaign between 2004 and 2016 were included. Four screening procedures were used: Hemoccult II, Magstream, Hemoccult and Magstream combined, and OC Sensor. Data were crossed with the Digestive Cancer Registry of Calvados to detect CRCs diagnosed during this period. The main outcomes were CRC detection and the incidence rate of interval cancers. RESULTS Screening consisted of 325,083 tests in 134,498 patients. Of the 2580 CRCs detected in patients aged 50-74, 534 (20.7 %) were screen-detected. OC Sensor had the highest sensitivity for CRC detection (83.7 %, 95 % CI [76.8-89.1 %]) and the lowest interval cancer rate (2.0 per 10,000 person-years, 95 % CI [1.4-2.7]) compared with other screening tests, excluding combinations. The overall participation rate was 28.9 %. CONCLUSION Real-life differences in performance between different screening tests exist, and OC Sensor appears to be the best. The low participation rate suggests that the rate of screen-detected CRC could be higher.
Collapse
|
|
6
|
Feng Z, Oberije CJG, van de Wetering AJP, Koch A, Wouters KAD, Vaes N, Masclee AAM, Carvalho B, Meijer GA, Zeegers MP, Herman JG, Melotte V, van Engeland M, Smits KM. Lessons From a Systematic Literature Search on Diagnostic DNA Methylation Biomarkers for Colorectal Cancer: How to Increase Research Value and Decrease Research Waste? Clin Transl Gastroenterol 2022; 13:e00499. [PMID: 35584320 PMCID: PMC9236597 DOI: 10.14309/ctg.0000000000000499] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/03/2021] [Accepted: 04/22/2022] [Indexed: 12/24/2022] Open
Abstract
OBJECTIVES To improve colorectal cancer (CRC) survival and lower incidence rates, colonoscopy and/or fecal immunochemical test screening are widely implemented. Although candidate DNA methylation biomarkers have been published to improve or complement the fecal immunochemical test, clinical translation is limited. We describe technical and methodological problems encountered after a systematic literature search and provide recommendations to increase (clinical) value and decrease research waste in biomarker research. In addition, we present current evidence for diagnostic CRC DNA methylation biomarkers. METHODS A systematic literature search identified 331 diagnostic DNA methylation marker studies published before November 2020 in PubMed, EMBASE, Cochrane Library, and Google Scholar. For 136 bodily fluid studies, extended data extraction was performed. STARD criteria and level of evidence were registered to assess reporting quality and strength for clinical translation. RESULTS Our systematic literature search revealed multiple issues that hamper the development of DNA methylation biomarkers for CRC diagnosis, including methodological and technical heterogeneity and lack of validation or clinical translation. For example, clinical translation and independent validation were limited, with 100 of 434 markers (23%) studied in bodily fluids, 3 of 434 markers (0.7%) translated into clinical tests, and independent validation for 92 of 411 tissue markers (22%) and 59 of 100 bodily fluids markers (59%). DISCUSSION This systematic literature search revealed that major requirements to develop clinically relevant diagnostic CRC DNA methylation markers are often lacking. To avoid the resulting research waste, clinical needs, intended biomarker use, and independent validation should be better considered before study design. In addition, improved reporting quality would facilitate meta-analysis, thereby increasing the level of evidence and enabling clinical translation.
Collapse
Affiliation(s)
- Zheng Feng
- Department of Pathology, GROW – School for Oncology and Reproduction, Maastricht University Medical Center, Maastricht, the Netherlands;
| | - Cary J. G. Oberije
- Department of Pathology, GROW – School for Oncology and Reproduction, Maastricht University Medical Center, Maastricht, the Netherlands;
- The D-Lab, Department of Precision Medicine, GROW—School for Oncology and Reproduction, Maastricht University Medical Centre, Maastricht, the Netherlands;
| | - Alouisa J. P. van de Wetering
- Department of Pathology, GROW – School for Oncology and Reproduction, Maastricht University Medical Center, Maastricht, the Netherlands;
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, Maastricht University Medical Center, Maastricht, the Netherlands;
| | - Alexander Koch
- Department of Pathology, GROW – School for Oncology and Reproduction, Maastricht University Medical Center, Maastricht, the Netherlands;
| | - Kim. A. D. Wouters
- Department of Pathology, GROW – School for Oncology and Reproduction, Maastricht University Medical Center, Maastricht, the Netherlands;
| | - Nathalie Vaes
- Department of Pathology, GROW – School for Oncology and Reproduction, Maastricht University Medical Center, Maastricht, the Netherlands;
| | - Ad A. M. Masclee
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, Maastricht University Medical Center, Maastricht, the Netherlands;
- Division of Gastroenterology-Hepatology, Department of Internal Medicine, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre, Maastricht, the Netherlands;
| | - Beatriz Carvalho
- Department of Pathology, Netherlands Cancer Institute, Amsterdam, the Netherlands;
| | - Gerrit A. Meijer
- Department of Pathology, Netherlands Cancer Institute, Amsterdam, the Netherlands;
| | - Maurice P. Zeegers
- Department of Complex Genetics, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Center, Maastricht, the Netherlands;
- Department of Complex Genetics, CAPHRI – Care and Public Health Research Institute, Maastricht University Medical Center, Maastricht, the Netherlands;
| | - James G. Herman
- Division of Hematology/Oncology, University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania, USA
| | - Veerle Melotte
- Department of Pathology, GROW – School for Oncology and Reproduction, Maastricht University Medical Center, Maastricht, the Netherlands;
- Department of Clinical Genetics, Erasmus University Medical Center, University of Rotterdam, Rotterdam, the Netherlands;
| | - Manon van Engeland
- Department of Pathology, GROW – School for Oncology and Reproduction, Maastricht University Medical Center, Maastricht, the Netherlands;
| | - Kim M. Smits
- Department of Pathology, GROW – School for Oncology and Reproduction, Maastricht University Medical Center, Maastricht, the Netherlands;
- Division of Medical Oncology, Department of Internal Medicine, GROW – School for Oncology and Reproduction, Maastricht University Medical Center, Maastricht, the Netherlands.
| |
Collapse
|
|
7
|
Saw KS, Liu C, Xu W, Varghese C, Parry S, Bissett I. Faecal immunochemical test to triage patients with possible colorectal cancer symptoms: meta-analysis. Br J Surg 2021; 109:182-190. [PMID: 34907419 PMCID: PMC10364725 DOI: 10.1093/bjs/znab411] [Citation(s) in RCA: 11] [Impact Index Per Article: 2.8] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/25/2021] [Accepted: 10/31/2021] [Indexed: 12/19/2022]
Abstract
BACKGROUND This review evaluated the utility of single quantitative faecal immunochemical test (FIT) as a triaging tool for patients with symptoms of possible colorectal cancer, the effect of symptoms on FIT accuracy, and the impact of triaging incorporating FIT on service provision. METHODS Five databases were searched. Meta-analyses of the extracted FIT sensitivities and specificities for detection of colorectal cancer at reported f-Hb thresholds were performed. Secondary outcomes included sensitivity and specificity of FIT for advanced colorectal neoplasia and serious bowel disease. Subgroup analysis by FIT brand and symptoms was undertaken. RESULTS Fifteen prospective cohort studies, including 28 832 symptomatic patients were included. At the most commonly reported f-Hb positivity threshold of ≥ 10 µg Hb/g faeces (n=13), the summary sensitivity was 88.7% (95% c.i. 85.2 to 91.4) and the specificity was 80.5% (95% c.i. 75.3 to 84.8) for colorectal cancer. At lower limits of detection of ≥ 2 µg Hb/g faeces, the summary sensitivity was 96.8% (95% c.i. 91.0 to 98.9) and the specificity was 65.6% (95% c.i. 59.0 to 71.6). At the upper f-Hb positivity thresholds of ≥ 100 µg Hb/g faeces and ≥ 150 µg Hb/g faeces, summary sensitivities were 68.1% (95% c.i. 59.2 to 75.9) and 66.3% (95% c.i. 52.2 to 78.0), with specificities of 93.4% (95% c.i. 91.3 to 95.1) and 95.1% (95% c.i. 93.6 to 96.3) respectively. FIT sensitivity was comparable between different assay brands. FIT sensitivity may be higher in patients reporting rectal bleeding. CONCLUSION Single quantitative FIT at lower f-Hb positivity thresholds can adequately exclude colorectal cancer in symptomatic patients and provides a data-based approach to prioritization of colonoscopy resources.
Collapse
Affiliation(s)
- Kai Sheng Saw
- Department of Surgery, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand
| | - Chen Liu
- Department of Surgery, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand
| | - William Xu
- Department of Surgery, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand
| | - Chris Varghese
- Department of Surgery, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand
| | - Susan Parry
- Department of Medicine, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand
| | - Ian Bissett
- Department of Surgery, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand
| |
Collapse
|
|
8
|
D'Souza N, Georgiou Delisle T, Chen M, Benton S, Abulafi M, The NICE FIT Steering Group
WarrenOliverAhmadiSaidyousufParchmentCarleneShanmuganandanArunWestNicholasMitchellToniSahStephenJacksonNickMyersAlistairZiprinPaulBloomIanKayeStanRamwellAndyJenkinsJohn TMonahanKevin. Faecal immunochemical test is superior to symptoms in predicting pathology in patients with suspected colorectal cancer symptoms referred on a 2WW pathway: a diagnostic accuracy study. Gut 2021; 70:1130-1138. [PMID: 33087488 PMCID: PMC8108285 DOI: 10.1136/gutjnl-2020-321956] [Citation(s) in RCA: 103] [Impact Index Per Article: 25.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/24/2020] [Revised: 08/06/2020] [Accepted: 08/09/2020] [Indexed: 12/14/2022]
Abstract
OBJECTIVE To assess whether a faecal immunochemical test (FIT) could be used to select patients with suspected colorectal cancer (CRC) symptoms for urgent investigation. DESIGN Multicentre, double-blinded diagnostic accuracy study in 50 National Health Service (NHS) hospitals across England between October 2017 and December 2019. Patients referred to secondary care with suspected CRC symptoms meeting NHS England criteria for urgent 2 weeks wait referral and triaged to investigation with colonoscopy were invited to perform a quantitative FIT. The sensitivity of FIT for CRC, and effect of relevant variables on its diagnostic accuracy was assessed. RESULTS 9822 patients were included in the final analysis. The prevalence of CRC at colonoscopy was 3.3%. The FIT positivity decreased from 37.2% to 19.0% and 7.6%, respectively, at cut-offs of 2, 10 and 150 µg haemoglobin/g faeces (µg/g). The positive predictive values of FIT for CRC at these cut-offs were 8.7% (95% CI, 7.8% to 9.7%), 16.1% (95% CI 14.4% to 17.8%) and 31.1% (95% CI 27.8% to 34.6%), respectively, and the negative predictive values were 99.8% (95% CI 99.7% to 99.9%), 99.6% (95% CI 99.5% to 99.7%) and 98.9% (95% CI 98.7% to 99.1%), respectively. The sensitivity of FIT for CRC decreased at the same cut-offs from 97.0% (95% CI 94.5% to 98.5%) to 90.9% (95% CI 87.2% to 93.8%) and 70.8% (95% CI 65.6% to 75.7%), respectively, while the specificity increased from 64.9% (95% CI 63.9% to 65.8%) to 83.5% (95% CI 82.8% to 84.3%) and 94.6% (95% CI 94.1% to 95.0%), respectively. The area under the receiver operating characteristic curve was 0.93 (95% CI 0.92 to 0.95). CONCLUSION FIT sensitivity is maximised to 97.0% at the lowest cut-off (2 µg/g); a negative FIT result at this cut-off can effectively rule out CRC and a positive FIT result is better than symptoms to select patients for urgent investigations. TRIAL REGISTRATION NUMBER ISRCTN49676259.
Collapse
Affiliation(s)
- Nigel D'Souza
- Colorectal Surgery, Croydon University Hospital, Croydon, UK,Colorectal Surgery, Basingstoke and North Hampshire Hospital, Basingstoke, UK,Surgery & Cancer, Imperial College London, London, UK
| | - Theo Georgiou Delisle
- Colorectal Surgery, Croydon University Hospital, Croydon, UK,Surgery & Cancer, Imperial College London, London, UK
| | | | - Sally Benton
- Clinical Biochemistry, Royal Surrey County Hospital, Guildford, UK
| | - Muti Abulafi
- Colorectal Surgery, Croydon University Hospital, Croydon, UK
| | | |
Collapse
|
|
9
|
Ito S, Hotta K, Imai K, Kishida Y, Takizawa K, Kakushima N, Kawata N, Yoshida M, Yabuuchi Y, Ishiwatari H, Matsubayashi H, Shiomi A, Ono H. Ultrathin colonoscopy can improve complete preoperative colonoscopy for stenotic colorectal cancer: Prospective observational study. Dig Endosc 2021; 33:621-628. [PMID: 32867005 DOI: 10.1111/den.13829] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/07/2020] [Revised: 08/18/2020] [Accepted: 08/21/2020] [Indexed: 01/15/2023]
Abstract
OBJECTIVES Preoperative colonoscopy is often incomplete for stenotic colorectal cancers (CRC). This prospective observational study aimed to evaluate the ability of an ultrathin colonoscope (UTC) to inspect the whole colon by passing through the stenotic CRC. METHODS All patients who underwent preoperative colonoscopy for stenotic CRCs at Shizuoka Cancer Center were examined for eligibility. If a standard colonoscope (PCF-H290ZI) could not pass because of a stenosis, the patients were recruited. All of the eligible patients were prospectively enrolled when informed consent could be obtained, and complete colonoscopy was attempted again using an UTC (PCF-PQ260L). Patients with stent placement and those requiring right hemicolectomy were not recruited. Primary endpoints were pass-through and cecal intubation rates. The detected synchronous neoplasias (adenomas and cancers) and their pathological findings after resection were evaluated. RESULTS A total of 100 patients were enrolled between September 2017 and February 2019. The mean age was 65.6 ± 10.8 years, and 59% were male. The pass-through and cecal intubation rates were 67% (67/100) and 58% (58/100), respectively. Synchronous lesions located proximal to the stenoses were detected in 65.5% (38/58) of the complete colonoscopies, with a total of 86 lesions, including 18 advanced neoplasias with three invasive cancers. CONCLUSION When standard colonoscopy cannot pass through stenotic CRC, ultrathin colonoscopy can be considered as an option to inspect the whole colon proximal to the stenosis because treatment strategy can potentially be changed by detecting synchronous neoplasias proximal to the stenosis before surgery. (UMIN000028505).
Collapse
Affiliation(s)
- Sayo Ito
- Divisions of, Division of, Endoscopy, Shizuoka Cancer Center, Shizuoka, Japan
| | - Kinichi Hotta
- Divisions of, Division of, Endoscopy, Shizuoka Cancer Center, Shizuoka, Japan
| | - Kenichiro Imai
- Divisions of, Division of, Endoscopy, Shizuoka Cancer Center, Shizuoka, Japan
| | - Yoshihiro Kishida
- Divisions of, Division of, Endoscopy, Shizuoka Cancer Center, Shizuoka, Japan
| | - Kohei Takizawa
- Divisions of, Division of, Endoscopy, Shizuoka Cancer Center, Shizuoka, Japan
| | - Naomi Kakushima
- Divisions of, Division of, Endoscopy, Shizuoka Cancer Center, Shizuoka, Japan
| | - Noboru Kawata
- Divisions of, Division of, Endoscopy, Shizuoka Cancer Center, Shizuoka, Japan
| | - Masao Yoshida
- Divisions of, Division of, Endoscopy, Shizuoka Cancer Center, Shizuoka, Japan
| | - Yohei Yabuuchi
- Divisions of, Division of, Endoscopy, Shizuoka Cancer Center, Shizuoka, Japan
| | | | | | - Akio Shiomi
- Division of, Colon and Rectal Surgery, Shizuoka Cancer Center, Shizuoka, Japan
| | - Hiroyuki Ono
- Divisions of, Division of, Endoscopy, Shizuoka Cancer Center, Shizuoka, Japan
| |
Collapse
|
|
10
|
PPV and Detection Rate of mt-sDNA Testing, FIT, and CT Colonography for Advanced Neoplasia: A Hierarchic Bayesian Meta-Analysis of the Noninvasive Colorectal Screening Tests. AJR Am J Roentgenol 2021; 217:817-830. [PMID: 33703913 DOI: 10.2214/ajr.20.25416] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/14/2022]
Abstract
BACKGROUND. Noninvasive tests for colorectal cancer (CRC) screening and prevention limit the need for invasive colonoscopy to follow up positive test results. However, the relative performance characteristics of available noninvasive tests have not yet been adequately compared. OBJECTIVE. We performed a systematic review and meta-analysis to compare the diagnostic performance of the available noninvasive CRC screening tests, including multitarget stool DNA (mt-sDNA) testing, fecal immunochemical testing (FIT), and CT colonography (CTC), with an emphasis on comparison of PPV and detection rate (DR) for advanced neoplasia (AN; encompassing cases of advanced adenomas and CRC). EVIDENCE ACQUISITION. After systematic searches of MEDLINE and Google Scholar databases, 10 mt-sDNA, 27 CTC, and 88 FIT published screening studies involving 25,132, 33,493, and 2,355,958 asymptomatic adults, respectively, were included. Meta-analysis with hierarchic Bayesian modeling was conducted in accordance with Cochrane Collaboration and PRISMA guidelines to determine test positivity rates (TPRs) leading to optical colonoscopy, as well as PPVs and DRs for both AN and CRC. Different positivity thresholds were considered for FIT and CTC. EVIDENCE SYNTHESIS. Point estimates (with 95% credible intervals) from pooled Bayesian meta-analysis combining all thresholds for FIT and stratifying CTC results by a polyp size threshold of 6 mm or larger (CTC6) and 10 mm or larger (CTC10) were calculated. TPR was 13.5% (10.9-16.6%) for mt-sDNA testing, 6.4% (5.8-7.2%) for FIT, 13.4% (11.4-15.6%) for CTC6, and 6.6% (5.2-7.7%) for CTC10. AN PPV was 26.9% (95% credible interval, 21.8-33.2%) for mt-sDNA testing, 31.8% (29.3-34.5%) for FIT, 34.4% (27.2-41.0%) for CTC6, and 61.0% (54.0-70.0%) for CTC10. CRC PPV was 2.4% (1.5-3.9%) for mt-sDNA testing, 4.9% (4.3-5.3%) for FIT, 3.5% (2.5-4.8%) for CTC6, and 6.0% (4.3-8.0%) for CTC10. The DR for AN was 3.4% (95% credible interval, 2.5-4.8%) for mt-SDNA, 2.0% (1.8-2.3%) for FIT, 4.8% (4.0-6.5%) for CTC6, and 4.0% (3.0-4.6%) for CTC10. When FIT is restricted to a lower threshold (< 10 μg Hb/g feces), its performance profile is similar to that of mt-sDNA testing, although available data are limited. AN PPV odds ratios (relative to CTC10 as the reference) were 0.24 (95% credible interval, 0.17-0.33) for mt-sDNA testing, 0.30 (0.24-0.45) for FIT, and 0.33 (0.25-0.47) for CTC6. CONCLUSION. Among noninvasive CRC screening tests, CTC with a polyp size threshold of 10 mm or larger most effectively targets AN, preserving detection while also decreasing unnecessary colonoscopies compared with mt-sDNA testing and FIT. CLINICAL IMPACT. CTC performed with a polyp size threshold for colonoscopy referral set at 10 mm or larger represents the most effective and efficient noninvasive screening test for CRC prevention and detection.
Collapse
|
|
11
|
O'Reilly SM, MacNally S, O'Donoghue D, Mooney T, Fitzpatrick P, Mulcahy HE, Cullen G. Correlation of Fecal Immunochemical Testing Levels With Pathology Results in a National Colorectal Cancer Screening Program. Clin Transl Gastroenterol 2021; 12:e00277. [PMID: 33512944 PMCID: PMC7806233 DOI: 10.14309/ctg.0000000000000277] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/20/2019] [Accepted: 06/08/2020] [Indexed: 12/31/2022] Open
Abstract
INTRODUCTION Fecal immunochemical testing (FIT) positivity is determined by a threshold decided by individual screening programs. Data are limited on correlation between FIT levels and pathology identified at colonoscopy. Our aim was to examine the correlation between FIT levels and pathology identified in a national colorectal cancer screening program. METHODS FIT levels (n = 9,271) were analyzed and correlated with patient demographics and pathology identified, including adenomas, sessile serrated lesions, number/size of adenomas, and presence of dysplasia. Levels were divided into 2 categories: FIT levels were defined as "high" or "low" based on whether they were above or below the median (479 ngHb/mL). Multivariate analysis was performed. RESULTS A total of 8,084 patients (87%) underwent colonoscopy. Those younger than 65 years (odds ratio [OR] 1.267, 95% confidence interval [CI] 1.107-1.45, P = 0.001), those with an adenoma >10 mm (OR 1.736, 95% CI 01.512-1.991, P < 0.001), and those with left-sided adenomas (OR 1.484, 95% CI 1.266-1.74, P < 0.001) had higher FIT levels. Cancers (OR 2.8, 95% CI 2.09-3.75, P < 0.001) and high-grade dysplasia (OR 1.356, 95% CI 1.08-1.7, P = 0.008) had higher FIT levels, but varied greatly. The number of adenomas was not significant. DISCUSSION In this study, FIT levels were high for left-sided and large adenomas, suggesting that FIT has poor sensitivity for detection of diminutive and right-sided neoplasia. FIT levels had no association with gender and declined with age. Adenoma burden did not correlate with FIT levels; this is a novel finding. FIT levels vary greatly even in those with advanced neoplasia; therefore, FIT is unlikely to be useful as a risk stratification tool.
Collapse
Affiliation(s)
- Susanne M. O'Reilly
- Center for Colorectal Disease, St Vincent's University Hospital, Dublin 4, Ireland
| | - Sara MacNally
- National Screening Service, Kings Inn House, Dublin 1, Ireland
| | | | - Therese Mooney
- National Screening Service, Kings Inn House, Dublin 1, Ireland
| | | | - Hugh E. Mulcahy
- Center for Colorectal Disease, St Vincent's University Hospital, Dublin 4, Ireland
| | - Garret Cullen
- Center for Colorectal Disease, St Vincent's University Hospital, Dublin 4, Ireland
| |
Collapse
|
|
12
|
Making FIT Count: Maximizing Appropriate Use of the Fecal Immunochemical Test for Colorectal Cancer Screening Programs. J Gen Intern Med 2020; 35:1870-1874. [PMID: 32128688 PMCID: PMC7280423 DOI: 10.1007/s11606-020-05728-y] [Citation(s) in RCA: 8] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/23/2019] [Accepted: 02/10/2020] [Indexed: 02/06/2023]
Abstract
Colorectal cancer (CRC) remains one of the most common and deadly malignancies despite advancements in screening, diagnostic capabilities, and treatment. The ability to detect and remove precancerous and cancerous lesions via screening has altered the epidemiology of the disease, decreasing incidence, mortality, and late-stage disease presentation. The fecal immunochemical test (FIT) is a screening test that aims to detect human hemoglobin in the stool. FIT is the most common CRC screening modality worldwide and second most common in the United States. Its use in screening programs has been shown to increase screening uptake and improve CRC outcomes. However, FIT-based screening programs vary widely in quality and effectiveness. In health systems with high-quality FIT screening programs, only superior FIT formats are used, providers order FIT appropriately, annual patient participation is high, and diagnostic follow-up after an abnormal result is achieved in a timely manner. Proper utilization of FIT involves multiple steps beyond provider recommendation of the test. In this commentary, we aim to highlight ongoing challenges in FIT screening and suggest interventions to maximize FIT effectiveness. Through active engagement of patients and providers, health systems can use FIT to help optimize CRC screening rates and improve CRC outcomes.
Collapse
|
|
13
|
Berry E, Miller S, Koch M, Balasubramanian B, Argenbright K, Gupta S. Lower Abnormal Fecal Immunochemical Test Cut-Off Values Improve Detection of Colorectal Cancer in System-Level Screens. Clin Gastroenterol Hepatol 2020; 18:647-653. [PMID: 31085338 PMCID: PMC7731666 DOI: 10.1016/j.cgh.2019.04.077] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/17/2018] [Revised: 04/24/2019] [Accepted: 04/26/2019] [Indexed: 02/06/2023]
Abstract
BACKGROUND & AIMS Noninvasive tests used in colorectal cancer screening, such as the fecal immunochemical test (FIT), are more acceptable but detect neoplasias with lower levels of sensitivity than colonoscopy. We investigated whether lowering the cut-off concentration of hemoglobin for designation as an abnormal FIT result increased the detection of advanced neoplasia in a mailed outreach program. METHODS We performed a prospective study of 17,017 uninsured patients, age 50 to 64 years, who were not current with screening and enrolled in a safety-net system in Texas. We reduced the cut-off value for an abnormal FIT result from 20 or more to 10 or more μg hemoglobin/g feces a priori. All patients with abnormal FIT results were offered no-cost diagnostic colonoscopy. We compared proportions of patients with abnormal FIT results and neoplasia yield for standard vs lower cut-off values, as well as absolute hemoglobin concentration distribution among 5838 persons who completed the FIT. Our primary aim was to determine the effects of implementing a lower hemoglobin concentration cut-off value on colonoscopy demand and yield, specifically colorectal cancer (CRC) and advanced neoplasia detection, compared with the standard, higher, hemoglobin concentration cut-off value. RESULTS The proportions of patients with abnormal FIT results were 12.3% at the 10 or more μg hemoglobin/g feces and 6.6% at the standard 20 or more μg hemoglobin/g feces cut-off value (P = .0013). Detection rates for the lower vs the standard threshold were 10.2% vs 12.7% for advanced neoplasia (P = .12) and 0.9% vs 1.2% for CRC (P = .718). The positive predictive values were 18.9% for the lower threshold vs 24.4% for the standard threshold for advanced neoplasia (P = .053), and 1.7% vs 2.4% for CRC (P = .659). The number needed to screen to detect 1 case with advanced neoplasia was 45 at the lower threshold compared with 58 at the standard threshold; the number needed to scope to detect 1 case with advanced neoplasia increased from 4 to 5. Most patients with CRC (72.7%) or advanced adenoma (67.3%) had hemoglobin concentrations of 20 or more μg/g feces. In the group with 10 to 19 μg hemoglobin/g feces, there were 3 patients with CRC (3 of 11; 27.3%) and 36 with advanced adenoma (36 of 110; 32.7%) who would not have been detected at the standard positive threshold (advanced neoplasia Pcomparison < .001). The proportion of patients found to have no neoplasia after an abnormal FIT result (false positives) was not significantly higher with the lower cut-off value (44.4%) than the standard cut-off value (39.1%) (P = .1103). CONCLUSIONS In a prospective study of 17,017 uninsured patients, we found that reducing the abnormal FIT result cut-off value (to ≥10 μg hemoglobin/g feces) might increase detection of advanced neoplasia, but doubled the proportion of patients requiring a diagnostic colonoscopy. If colonoscopy capacity permits, health systems that use quantitative FITs should consider lowering the abnormal cut-off value to optimize CRC detection and prevention. (ClinicalTrials.gov no: NCT01946282.).
Collapse
Affiliation(s)
- Emily Berry
- Moncrief Cancer Institute, Fort Worth, Texas.
| | | | - Mark Koch
- Department of Family Medicine, John Peter Smith Health Network, Fort Worth, Texas
| | - Bijal Balasubramanian
- Department of Epidemiology, Genetics, and Environmental Science, University of Texas School of Public Health Dallas Regional Campus, Dallas, Texas
| | - Keith Argenbright
- Moncrief Cancer Institute, Fort Worth, Texas; Harold C. Simmons Cancer Center, Dallas, Texas; Department of Clinical Sciences, University of Texas Southwestern Medical Center, Dallas, Texas
| | - Samir Gupta
- San Diego Veterans Affairs Healthcare System, San Diego, California; Division of Gastroenterology, Department of Internal Medicine, Moores Cancer Center, University of California San Diego, San Diego, California.
| |
Collapse
|
|
14
|
Senore C, Zappa M, Campari C, Crotta S, Armaroli P, Arrigoni A, Cassoni P, Colla R, Fracchia M, Gili F, Grazzini G, Lolli R, Menozzi P, Orione L, Polizzi S, Rapi S, Riggi E, Rubeca T, Sassatelli R, Visioli C, Segnan N. Faecal haemoglobin concentration among subjects with negative FIT results is associated with the detection rate of neoplasia at subsequent rounds: a prospective study in the context of population based screening programmes in Italy. Gut 2020; 69:523-530. [PMID: 31455608 DOI: 10.1136/gutjnl-2018-318198] [Citation(s) in RCA: 22] [Impact Index Per Article: 4.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/28/2018] [Revised: 08/07/2019] [Accepted: 08/11/2019] [Indexed: 12/19/2022]
Abstract
OBJECTIVE To estimate the predictive role of faecal haemoglobin (f-Hb) concentration among subjects with faecal immunochemical test (FIT) results below the positivity cut-off for the subsequent risk of advanced neoplasia (AN: colorectal cancer-CRC-or advanced adenoma). DESIGN Prospective cohort of subjects aged 50-69 years, undergoing their first FIT between 1 January 2004 and 31 December 2010 in four population-based programmes in Italy. METHODS All programmes adopted the same analytical procedure (OC Sensor, Eiken Japan), performed every 2 years, on a single sample, with the same positivity cut-off (20 µg Hb/g faeces). We assessed the AN risk at subsequent exams, the cumulative AN detection rate (DR) over the 4-year period following the second FIT and the interval CRC (IC) risk following two negative FITs by cumulative amount of f-Hb concentration over two consecutive negative FITs, using multivariable logistic regression models and the Kaplan-Meier method. RESULTS The cumulative probability of a positive FIT result over the subsequent two rounds ranged between 7.8% (95% CI 7.5 to 8.2) for subjects with undetectable f-Hb at the initial two tests (50% of the screenees) and 48.4% (95% CI 44.0 to 53.0) among those (0.7% of the screenees) with a cumulative f-Hb concentration ≥20 µg/g faeces. The corresponding figures for cumulative DR were: 1.4% (95% CI 1.3 to 1.6) and 25.5% (95% CI 21.4 to 30.2) for AN; 0.17% (95% CI 0.12 to 0.23) and 4.5% (95% CI 2.8 to 7.1) for CRC. IC risk was also associated with cumulative f-Hb levels. CONCLUSION The association of cumulative f-Hb concentration with subsequent AN and IC risk may allow to design tailored strategies to optimise the utilisation of endoscopy resources: subjects with cumulative f-Hb concentration ≥20 µg/g faeces over two negative tests could be referred immediately for total colonoscopy (TC), while screening interval might be extended for those with undetectable f-Hb.
Collapse
Affiliation(s)
- Carlo Senore
- SSD Epidemiologia e screening - CPO, University Hospital Città della Salute e della Scienza, Turin, Italy
| | - Marco Zappa
- Clinical Epidemiology Unit, ISPRO, Florence, Italy
| | - Cinzia Campari
- Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy
| | | | - Paola Armaroli
- SSD Epidemiologia e screening - CPO, University Hospital Città della Salute e della Scienza, Turin, Italy
| | - Arrigo Arrigoni
- University Gastroenterology Unit, Ospedale San Giovanni Antica Sede, Turin, Italy
| | - Paola Cassoni
- Department of Medical Sciences, Universita degli Studi di Torino, Turin, Italy
| | - Rossana Colla
- Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy
| | - Mario Fracchia
- Gastroenterology Unit, Mauriziano Umberto I Hospital, Turin, Italy
| | - Fabrizio Gili
- Colorectal Cancer Screening Laboratory, University Hospital Città della Salute e della Scienza, Turin, Italy
| | | | - Roberto Lolli
- Gastroenterology Unit, Regional Hospital, Aosta, Italy
| | | | | | | | | | - Emilia Riggi
- SSD Epidemiologia e screening - CPO, University Hospital Città della Salute e della Scienza, Turin, Italy
| | | | | | | | - Nereo Segnan
- SSD Epidemiologia e screening - CPO, University Hospital Città della Salute e della Scienza, Turin, Italy
| |
Collapse
|
|
15
|
Guo F, De Brabander I, Francart J, Candeur M, Polus M, Van Eycken L, Brenner H. Benefits of switching from guaiac-based faecal occult blood to faecal immunochemical testing: experience from the Wallonia-Brussels colorectal cancer screening programme. Br J Cancer 2020; 122:1109-1117. [PMID: 32066910 PMCID: PMC7109124 DOI: 10.1038/s41416-020-0754-5] [Citation(s) in RCA: 11] [Impact Index Per Article: 2.2] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/26/2019] [Revised: 01/20/2020] [Accepted: 01/30/2020] [Indexed: 12/24/2022] Open
Abstract
Background Faecal immunochemical tests (FITs) have replaced guaiac-based faecal occult blood test (gFOBTs) in several colorectal cancer (CRC) screening programmes. We aimed to evaluate the benefits of this transition based on the Wallonia–Brussels-organised CRC screening programme. Methods A total of 1,569,868 individuals aged 50–74 years, who were invited to screening during 2009–2017, were studied by linking their screening records with insurance, pathology and cancer data in the Belgian Cancer Registry. We compared neoplasm detection rates and positive predictive values (PPVs) of gFOBT and FIT at 15 µg haemoglobin per gram cut-off in screen-naive individuals. We furthermore examined the incidence rates of interval cancer in gFOBT- and FIT-based screening programme. Results Advanced neoplasms were detected less frequently by gFOBT (0.8%) than by FIT (1.3%), with a difference of 0.5% (P < 0.01). PPVs were lower for gFOBT (15.1%) than for FIT (21.7%) for advanced neoplasms (difference 6.6%, P < 0.01). Compared to participants with negative gFOBT, those with negative FIT were 77% less likely to develop interval cancer (incidence rate ratio 0.23, 95% confidence interval 0.16–0.33). Conclusion Our study demonstrated that in an organised CRC screening programme, replacing gFOBT with FIT improved neoplasm detection rate and substantially reduced interval cancer incidence.
Collapse
Affiliation(s)
- Feng Guo
- Division of Clinical Epidemiology and Aging Research, German Cancer Research Center (DKFZ), Heidelberg, Germany.,Medical Faculty Heidelberg, University of Heidelberg, Heidelberg, Germany
| | | | | | - Michel Candeur
- Community Reference Center for Cancer Screening (Wallonia), Mont-Saint-Guibert, Belgium
| | - Marc Polus
- Department of Gastroenterology, University Hospital of Liège, Liège, Belgium
| | | | - Hermann Brenner
- Division of Clinical Epidemiology and Aging Research, German Cancer Research Center (DKFZ), Heidelberg, Germany. .,Division of Preventive Oncology, German Cancer Research Center (DKFZ) and National Center for Tumor Diseases (NCT), Heidelberg, Germany. .,German Cancer Consortium (DKTK), German Cancer Research Center (DKFZ), Heidelberg, Germany.
| |
Collapse
|
|
16
|
Alexandre L, Manning C, Chan SSM. Prevalence of gastrointestinal malignancy in iron deficiency without anaemia: A systematic review and meta-analysis. Eur J Intern Med 2020; 72:27-33. [PMID: 31932190 DOI: 10.1016/j.ejim.2019.12.015] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/27/2019] [Revised: 12/14/2019] [Accepted: 12/19/2019] [Indexed: 12/11/2022]
Abstract
BACKGROUND Iron deficiency anaemia is associated with gastrointestinal (GI) malignancy and is an indication for GI investigations. However, the relevance of iron deficiency without anaemia (IDWA) and the underlying risks of GI malignancy are uncertain. Therefore, the aim of this study was to estimate the prevalence of GI malignancy in patients with IDWA overall and in clinically relevant subgroups. METHODS We searched MEDLINE and EMBASE for studies that reported on the prevalence or risk of GI malignancy in patients with confirmed IDWA. We performed a random effects meta-analysis of proportions and assessed statistical heterogeneity using the I2 statistic. RESULTS A total of 1923 citations were screened and 5 studies (4 retrospective cohorts, 1 prospective cohort) comprising 3329 participants with IDWA were included in the meta-analysis. Overall pooled random-effects estimates for prevalence of GI malignancy in those with IDWA were low (0.38%, 95% CI 0.00%-1.84%, I2 = 87.7%). Older patients (2.58%, 95% CI 0.00%-8.77%); non-screening populations (2.45%, 95% CI 0.16%-6.39%) and men and post-menopausal women (0.90%, 95% CI 0.11%-3.23%) with IDWA were at increased risk of GI malignancy compared to younger patients (0.00%, 95% CI 0.00%-0.21%); screened populations (0.24%, 95% CI 0.00%-1.10%) and pre-menopausal women (0.00%, 95% CI 0.00%-1.05%). CONCLUSION Overall, IDWA is associated with a low risk of GI malignancy. Older patients and non-screening populations are at elevated risk and require GI investigations. Those not in these subgroups have a lower risk of GI malignancy and may wish to be monitored following discussion of the risk and potential benefits of GI investigations.
Collapse
Affiliation(s)
- Leo Alexandre
- Norwich Medical School, University of East Anglia, Norwich NR4 7TJ, UK; Department of Gastroenterology, Norfolk and Norwich University Hospital, Norwich NR4 7UY, UK
| | - Charelle Manning
- Department of Gastroenterology, Norfolk and Norwich University Hospital, Norwich NR4 7UY, UK
| | - Simon S M Chan
- Norwich Medical School, University of East Anglia, Norwich NR4 7TJ, UK; Department of Gastroenterology, Norfolk and Norwich University Hospital, Norwich NR4 7UY, UK.
| |
Collapse
|
|
17
|
Hansen AT, Hoffmann-Lücke E, Nielsen BK, Reinholdt B, Hindersson P, Heidemann K, Hornung N. Delayed sample arrival at the laboratory does not lead to more false negatives in the Danish population screening for colorectal cancer. Scandinavian Journal of Clinical and Laboratory Investigation 2017; 77:685-688. [DOI: 10.1080/00365513.2017.1379091] [Citation(s) in RCA: 6] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 12/22/2022]
Affiliation(s)
- Anette Tarp Hansen
- Department of Clinical Biochemistry, Randers Regional Hospital, Randers, Denmark
- Department of Clinical Biochemistry, Aalborg University Hospital, Aalborg, Denmark
| | - Elke Hoffmann-Lücke
- Department of Clinical Biochemistry, Randers Regional Hospital, Randers, Denmark
| | - Betina Klint Nielsen
- Department of Clinical Biochemistry, Slagelse, Naestved, and Nykøbing Falster Hospitals, Slagelse, Denmark
| | | | - Peter Hindersson
- Department of Clinical Biochemistry, North Denmark Regional Hospital, Hjørring, Denmark
| | - Karin Heidemann
- Department of Clinical Biochemistry, Herlev and Gentofte Hospital, Hellerup, Denmark
| | - Nete Hornung
- Department of Clinical Biochemistry, Randers Regional Hospital, Randers, Denmark
| |
Collapse
|
|
18
|
Projected effect of fecal immunochemical test threshold for colorectal cancer screening on outcomes and costs for Canada using the OncoSim microsimulation model. J Cancer Policy 2017. [DOI: 10.1016/j.jcpo.2017.07.004] [Citation(s) in RCA: 6] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/22/2022]
|
|
19
|
Shin HY, Suh M, Baik HW, Choi KS, Park B, Jun JK, Hwang SH, Kim BC, Lee CW, Oh JH, Lee YK, Han DS, Lee DH. Performance of the Fecal Immunochemical Test for Colorectal Cancer Screening Using Different Stool-Collection Devices: Preliminary Results from a Randomized Controlled Trial. Gut Liver 2017; 10:925-931. [PMID: 27282262 PMCID: PMC5087932 DOI: 10.5009/gnl15479] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/22/2015] [Revised: 12/24/2015] [Accepted: 01/15/2016] [Indexed: 12/13/2022] Open
Abstract
Background/Aims We are in the process of conducting a randomized trial to determine whether compliance with the fecal immunochemical test (FIT) for colorectal cancer screening differs according to the stool-collection method. This study was an interim analysis of the performance of two stool-collection devices (sampling bottle vs conventional container). Methods In total, 1,701 individuals (age range, 50 to 74 years) were randomized into the sampling bottle group (intervention arm) or the conventional container group (control arm). In both groups, we evaluated the FIT positivity rate, the positive predictive value for advanced neoplasia, and the detection rate for advanced neoplasia. Results The FIT positivity rates were 4.1% for the sampling bottles and 2.0% for the conventional containers; these values were significantly different. The positive predictive values for advanced neoplasia in the sampling bottles and conventional containers were 11.1% (95% confidence interval [CI], −3.4 to 25.6) and 12.0% (95% CI, −0.7 to 24.7), respectively. The detection rates for advanced neoplasia in the sampling bottles and conventional containers were 4.5 per 1,000 persons (95% CI, 2.0 to 11.0) and 2.4 per 1,000 persons (95% CI, 0.0 to 5.0), respectively. Conclusions The impact of these findings on FIT screening performance was unclear in this interim analysis. This impact should therefore be evaluated in the final analysis following the final enrollment period.
Collapse
Affiliation(s)
- Hye Young Shin
- National Cancer Control Institute, National Cancer Center, Goyang, Korea
| | - Mina Suh
- National Cancer Control Institute, National Cancer Center, Goyang, Korea
| | - Hyung Won Baik
- National Cancer Control Institute, National Cancer Center, Goyang, Korea.,Lung Cancer Clinic, Severance Hospital, Yonsei University Health System, Seoul, Korea
| | - Kui Son Choi
- National Cancer Control Institute, National Cancer Center, Goyang, Korea
| | - Boyoung Park
- National Cancer Control Institute, National Cancer Center, Goyang, Korea
| | - Jae Kwan Jun
- National Cancer Control Institute, National Cancer Center, Goyang, Korea
| | - Sang-Hyun Hwang
- Department of Laboratory Medicine, Center for Diagnostic Oncology, National Cancer Center Hospital, National Cancer Center, Goyang, Korea
| | - Byung Chang Kim
- Center for Colorectal Cancer, National Cancer Center Hospital, National Cancer Center, Goyang, Korea
| | - Chan Wha Lee
- Center for Cancer Prevention & Detection, National Cancer Center Hospital, National Cancer Center, Goyang, Korea
| | - Jae Hwan Oh
- Center for Colorectal Cancer, National Cancer Center Hospital, National Cancer Center, Goyang, Korea
| | - You Kyoung Lee
- Department of Laboratory Medicine and Genetics, Soonchunhyang University Bucheon Hospital, Soonchunhyang University College of Medicine, Bucheon, Korea
| | - Dong Soo Han
- Department of Gastroenterology, Hanyang University Guri Hospital, Guri, Korea
| | - Do-Hoon Lee
- Department of Laboratory Medicine, Center for Diagnostic Oncology, National Cancer Center Hospital, National Cancer Center, Goyang, Korea
| |
Collapse
|
|
20
|
Idigoras I, Arrospide A, Portillo I, Arana-Arri E, Martínez-Indart L, Mar J, de Koning HJ, Lastra R, Soto-Gordoa M, van der Meulen M, Lansdorp-Vogelaar I. Evaluation of the colorectal cancer screening Programme in the Basque Country (Spain) and its effectiveness based on the Miscan-colon model. BMC Public Health 2017; 18:78. [PMID: 28764731 PMCID: PMC5540568 DOI: 10.1186/s12889-017-4639-3] [Citation(s) in RCA: 24] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/07/2016] [Accepted: 07/26/2017] [Indexed: 12/14/2022] Open
Abstract
Abstract The population-based Basque Colorectal Cancer (CRC) Screening Programme started in 2009 with a biennial immunochemical quantitative test (FIT) biennial and colonoscopy under sedation in positive cases. The population target of 586,700 residents was from 50 to 69 years old and the total coverage was reached at the beginning of 2014. The aim of our study was to determine possible scenarios in terms of incidence, mortality and reduction of Life-years-Lost (L-y-L) in the medium and long term of CRC. Methods Invitations were sent out by the Programme from 2009 to 2014, with combined organizational strategies. Simulation was done by MISCAN-colon (Microsimulation Screening Analysis) over 30 years comparing the results of screening vs no-screening, taking the population-based Cancer Registry into account. Lifetime population and real data from the Programme were used from 2008 to 2012. The model was run differentially for men and women. Results 924,416 invitations were sent out from 2009 to 2014. The average participation rate was 68.4%, CRC detection rate was 3.4% and the Advanced Adenoma detection rate was 24.0‰, with differences observed in sex and age. Future scenarios showed a higher decrease of incidence (17.2% vs 14.7%), mortality (28.1% vs 22.4%) and L-y-L (22.6% vs 18.4%) in men than women in 2030. Conclusions The Basque Country CRC Programme results are aligned to its strategy and comparable to other programmes. MISCAN model was found to be a useful tool to predict the benefits of the programme in the future. The effectiveness of the Programme has not been formally established as case control studies are required to determine long term benefits from the screening strategy.
Collapse
Affiliation(s)
- I Idigoras
- Basque Country Colorectal Cancer Screening Programme, the Basque Health Service, Gran Vía, 62 - 4°, 48011, Bilbao, Spain. .,BioCruces Health Research Institute, Barakaldo, Spain.
| | - A Arrospide
- Gipuzkoa Primary Care - Integrated Health Care Organizations Research Unit. Alto Deba Integrated Health Care Organization, Gipuzkoa, Spain.,Health Services Research on Chronic Patients Network (REDISSEC), Mondragón, Spain.,Biodonostia Health Research Institute, San Sebastian-, Donostia, Spain
| | - I Portillo
- Basque Country Colorectal Cancer Screening Programme, the Basque Health Service, Gran Vía, 62 - 4°, 48011, Bilbao, Spain.,BioCruces Health Research Institute, Barakaldo, Spain
| | - E Arana-Arri
- BioCruces Health Research Institute, Barakaldo, Spain
| | | | - J Mar
- Gipuzkoa Primary Care - Integrated Health Care Organizations Research Unit. Alto Deba Integrated Health Care Organization, Gipuzkoa, Spain.,Health Services Research on Chronic Patients Network (REDISSEC), Mondragón, Spain.,Biodonostia Health Research Institute, San Sebastian-, Donostia, Spain
| | - H J de Koning
- Department of Public Health, Erasmus MC, University Medical Center, Rotterdam, The Netherlands
| | - R Lastra
- Department of Information Technologies, The Basque Health Service, Vitoria-Gasteiz, Spain
| | - M Soto-Gordoa
- Gipuzkoa Primary Care - Integrated Health Care Organizations Research Unit. Alto Deba Integrated Health Care Organization, Gipuzkoa, Spain.,Health Services Research on Chronic Patients Network (REDISSEC), Mondragón, Spain.,Biodonostia Health Research Institute, San Sebastian-, Donostia, Spain
| | - M van der Meulen
- Department of Public Health, Erasmus MC, University Medical Center, Rotterdam, The Netherlands
| | - I Lansdorp-Vogelaar
- Department of Public Health, Erasmus MC, University Medical Center, Rotterdam, The Netherlands
| |
Collapse
|
|
21
|
Issa IA, Noureddine M. Colorectal cancer screening: An updated review of the available options. World J Gastroenterol 2017; 23:5086-5096. [PMID: 28811705 PMCID: PMC5537177 DOI: 10.3748/wjg.v23.i28.5086] [Citation(s) in RCA: 383] [Impact Index Per Article: 47.9] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/05/2017] [Revised: 05/02/2017] [Accepted: 06/19/2017] [Indexed: 02/06/2023] Open
Abstract
Colorectal cancer (CRC) is a significant cause of morbidity and mortality worldwide. However, colon cancer incidence and mortality is declining over the past decade owing to adoption of effective screening programs. Nevertheless, in some parts of the world, CRC incidence and mortality remain on the rise, likely due to factors including "westernized" diet, lifestyle, and lack of health-care infrastructure and resources. Participation and adherence to different national screening programs remain obstacles limiting the achievement of screening goals. Different modalities are available ranging from stool based tests to radiology and endoscopy with varying sensitivity and specificity. However, the availability of these tests is limited to areas with high economic resources. Recently, FDA approved a blood-based test (Epi procolon®) for CRC screening. This blood based test may serve to increase the participation and adherence rates. Hence, leading to increase in colon cancer detection and prevention. This article will discuss various CRC screening tests with a particular focus on the data regarding the new approved blood test. Finally, we will propose an algorithm for a simple cost-effective CRC screening program.
Collapse
|
|
22
|
Aniwan S, Ratanachu Ek T, Pongprasobchai S, Limsrivilai J, Praisontarangkul OA, Pisespongsa P, Mairiang P, Sangchan A, Sottisuporn J, Wisedopas N, Kullavanijaya P, Rerknimitr R. The Optimal Cut-Off Level of The Fecal Immunochemical Test For Colorectal Cancer Screening in a Country with Limited Colonoscopy Resources: A Multi-Center Study from Thailand. Asian Pac J Cancer Prev 2017; 18:405-412. [PMID: 28345822 PMCID: PMC5454735 DOI: 10.22034/apjcp.2017.18.2.405] [Citation(s) in RCA: 24] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Abstract] [Key Words] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/24/2022] Open
Abstract
Background: Selecting the cut-off point for the fecal immunochemical test (FIT) for colorectal cancer (CRC) screening programs is of prime importance. The balance between the test performance for detecting advanced neoplasia and the available colonoscopy resources should be considered. We aimed to identify the optimal cut-off of FIT for advanced neoplasia in order to minimize colonoscopy burden. Methods: We conducted a multi-center study in 6 hospitals from diverse regions of Thailand. Asymptomatic participants, aged 50-75 years, were tested with one-time quantitative FIT (OC-SENSOR, Eiken Chemical Co.,Ltd., Tokyo, Japan) and all participants underwent colonoscopy. We assessed test performance in detecting advanced neoplasia (advanced adenoma and CRC) and measured the burden of colonoscopy with different cut-offs [25 (FIT25), 50 (FIT50), 100 (FIT100), 150 (FIT150), and 200 (FIT200)ng/ml]. Results: Among 1,479 participants, advanced neoplasia and CRC were found in 137 (9.3%) and 14 (0.9%), respectively. From FIT25 to FIT200, the positivity rate decreased from 18% to 4.9%. For advanced neoplasia, an increased cut-off decreased sensitivity from 42.3% to 16.8% but increased specificity from 84.2% to 96.3%. The increased cut-off increased the positive predictive value (PPV) from 21.5% to 31.5%. However, all cut-off points provided a high negative predictive value (NPV) (>90%). For CRC, the miss rate for FIT25 to FIT 150 was the same (n=3, 21%), whereas that with FIT200 increased to 35% (n=5). Conclusions: In a country with limited-colonoscopy resources, using FIT150 may be preferred because it offers both high PPV and NPV for advanced neoplasia detection. It could also decrease colonoscopy workload, while maintaining a CRC miss rate similar to those with lower cut-offs.
Collapse
Affiliation(s)
- Satimai Aniwan
- Division of Gastroenterology, Department of Medicine, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital, The Thai Red Cross Society, Bangkok, Thailand.
| | | | | | | | | | | | | | | | | | | | | | | |
Collapse
|
|
23
|
Shahidi N, Gentile L, Gondara L, Hamm J, McGahan CE, Enns R, Telford J. Correlating Quantitative Fecal Immunochemical Test Results with Neoplastic Findings on Colonoscopy in a Population-Based Colorectal Cancer Screening Program: A Prospective Study. Can J Gastroenterol Hepatol 2016; 2016:4650471. [PMID: 28116286 PMCID: PMC5220421 DOI: 10.1155/2016/4650471] [Citation(s) in RCA: 7] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/18/2016] [Revised: 11/06/2016] [Accepted: 11/09/2016] [Indexed: 02/06/2023] Open
Abstract
Background and Aims. The Canadian Partnership Against Cancer (CPAC) recommends a fecal immunochemical test- (FIT-) positive predictive value (PPV) for all adenomas of ≥50%. We sought to assess FIT performance among average-risk participants of the British Columbia Colon Screening Program (BCCSP). Methods. From Nov-2013 to Dec-2014 consecutive participants of the BCCSP were assessed. Data was obtained from a prospectively collected database. A single quantitative FIT (NS-Plus, Alfresa Pharma Corporation, Japan) with a cut-off of ≥10 μg/g (≥50 ng/mL) was used. Results. 20,322 FIT-positive participants underwent CSPY. At a FIT cut-off of ≥10 μg/g (≥50 ng/mL) the PPV for all adenomas was 52.0%. Increasing the FIT cut-off to ≥20 μg/g (≥100 ng/mL) would increase the PPV for colorectal cancer (CRC) by 1.5% and for high-risk adenomas (HRAs) by 6.5% at a cost of missing 13.6% of CRCs and 32.4% of HRAs. Conclusions. As the NS-Plus FIT cut-off rises, the PPV for CRC and HRAs increases but at the cost of missed lesions. A cut-off of ≥10 μg/g (≥50 ng/mL) produces a PPV for all adenomas exceeding national recommendations. Health authorities need to take into consideration endoscopic resources when selecting a FIT positivity threshold.
Collapse
Affiliation(s)
- Neal Shahidi
- St. Paul's Hospital, Division of Gastroenterology, Department of Medicine, University of British Columbia, Vancouver, BC, Canada
| | - Laura Gentile
- British Columbia Cancer Agency, Vancouver, BC, Canada
| | | | - Jeremy Hamm
- British Columbia Cancer Agency, Vancouver, BC, Canada
| | | | - Robert Enns
- St. Paul's Hospital, Division of Gastroenterology, Department of Medicine, University of British Columbia, Vancouver, BC, Canada
| | - Jennifer Telford
- St. Paul's Hospital, Division of Gastroenterology, Department of Medicine, University of British Columbia, Vancouver, BC, Canada
- British Columbia Cancer Agency, Vancouver, BC, Canada
| |
Collapse
|
|
24
|
Wieten E, Schreuders EH, Nieuwenburg SAV, Hansen BE, Lansdorp-Vogelaar I, Kuipers EJ, Bruno MJ, Spaander MCW. Effects of Increasing Screening Age and Fecal Hemoglobin Cutoff Concentrations in a Colorectal Cancer Screening Program. Clin Gastroenterol Hepatol 2016; 14:1771-1777. [PMID: 27567693 DOI: 10.1016/j.cgh.2016.08.016] [Citation(s) in RCA: 19] [Impact Index Per Article: 2.1] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/22/2016] [Revised: 07/25/2016] [Accepted: 08/04/2016] [Indexed: 02/07/2023]
Abstract
BACKGROUND & AIMS Several countries have implemented programs to screen for colorectal cancer (CRC) by using the fecal immunochemical test (FIT). These programs vary considerably in age of the population screened and the cutoff concentration of fecal hemoglobin (Hb) used to identify candidates for further evaluation; these variations are usually based on a country's colonoscopy resources. We calculated how increasing the Hb cutoff concentration and screening age affects colonoscopy yield, missed lesions, and demand. METHODS We collected data from 10,008 average-risk individuals in The Netherlands, 50-74 years old, who were invited for an FIT in the first round of a population-based CRC screening program from November 2006 through December 2008. Fecal samples were collected, and levels of Hb were measured by using the OC-sensor Micro analyzer; concentrations ≥10 μg Hb/g feces were considered positive. Subjects with a positive FIT were scheduled for colonoscopy within 4 weeks. Logistic regression analysis was performed to evaluate the association between age and detection of advanced neoplasia. RESULTS In total, 5986 individuals (62%) participated in the study; 503 (8.4%) had a positive test result. Attendance, positive test results, detection of advanced neoplasia, and the FIT's positive predictive value all increased significantly with age (P < .001). Detection of advanced neoplasia ranged from 1.3% in the youngest age group to 6.2% in the oldest group; the positive predictive value of the FIT was 26% in the youngest group and 47% in the oldest group. Increasing the starting age of invitees from 50-74 years to 55-74 years reduced the proportion of subjects who underwent colonoscopy evaluation by 14% and resulted in 9% more subjects with advanced neoplasia being missed. Increasing the cutoff concentration from 10 to 15 μg Hb/g feces reduced the proportion of subjects who underwent colonoscopy evaluation by 11% and resulted in 6% of advanced neoplasia being missed. CONCLUSIONS In an analysis of an average-risk screening population in The Netherlands, we found that detection of advanced neoplasia by FIT increases significantly with age and fecal Hb cutoff concentration. Increasing the cutoff concentration or screening age reduces the numbers of patients who undergo colonoscopy evaluation in FIT-based CRC screening programs. Our findings provide insight in these effects per age category and cutoff concentration and the consequences in terms of missed lesions.
Collapse
Affiliation(s)
- Els Wieten
- Department of Gastroenterology and Hepatology, Erasmus MC University Medical Centre, Rotterdam, The Netherlands
| | - Eline H Schreuders
- Department of Gastroenterology and Hepatology, Erasmus MC University Medical Centre, Rotterdam, The Netherlands
| | - Stella A V Nieuwenburg
- Department of Gastroenterology and Hepatology, Erasmus MC University Medical Centre, Rotterdam, The Netherlands
| | - Bettina E Hansen
- Department of Gastroenterology and Hepatology, Erasmus MC University Medical Centre, Rotterdam, The Netherlands
| | - Iris Lansdorp-Vogelaar
- Department of Public Health, Erasmus MC University Medical Centre, Rotterdam, The Netherlands
| | - Ernst J Kuipers
- Department of Gastroenterology and Hepatology, Erasmus MC University Medical Centre, Rotterdam, The Netherlands
| | - Marco J Bruno
- Department of Gastroenterology and Hepatology, Erasmus MC University Medical Centre, Rotterdam, The Netherlands
| | - Manon C W Spaander
- Department of Gastroenterology and Hepatology, Erasmus MC University Medical Centre, Rotterdam, The Netherlands.
| |
Collapse
|
|
25
|
Extending Colorectal Cancer Screening to Persons Aged 40 to 49 Years With Immunochemical Fecal Occult Blood Test: A Prospective Cohort Study of 513,283 Individuals. J Clin Gastroenterol 2016; 50:761-8. [PMID: 26905605 DOI: 10.1097/mcg.0000000000000495] [Citation(s) in RCA: 15] [Impact Index Per Article: 1.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/07/2023]
Abstract
GOALS To assess the association between the initial immunochemical fecal occult blood tests (FIT) and subsequent colorectal cancer, and to explore the ability of FIT to identify individuals age 40 to 49 years with a higher cancer risk. BACKGROUND The number of cancer cases in this age group is increasing globally and the cancers found in younger age tend to be more advanced than in older age. METHODS A total of 513,283 individuals had FIT as part of their self-paying medical screening program between 1994 and 2008. The initial FIT test was used. When matched with the Taiwan cancer registry, the cohort identified 2138 colorectal cancer cases. The number needed to screen (NNS) to identify 1 cancer was calculated from the reciprocal of cancer incidence cases during the study period. RESULTS One in 7 colorectal cancers above age 40 years occurred in the age group of 40 to 49 years. Individuals 40 to 49 years old with positive FIT (≥100 ng/mL) had a 3 times larger cancer risk than those 50 to 59 years old and without FIT, or double the cancer risk as those 50 to 69 years old and without FIT, with NNS at 42, 135, and 95, respectively. A similar relationship existed for the cancer incidence rate. The HR for ages 40 to 44 years or 45 to 49 years with a positive FIT was 2.3 or 5.7 times larger than the HR for ages 50 to 54 years. There was a dose-response relationship between increasing FIT values and the cancer risk for each age group, including ages 40 to 49 years. CONCLUSIONS Offering FIT to individuals 40 to 49 years of age could identify higher-risk individuals earlier for follow-up colonoscopy, and could, in turn, reduce cancer mortality.
Collapse
|
|
26
|
Chen CH, Wen CP, Tsai MK. Fecal immunochemical test for colorectal cancer from a prospective cohort with 513,283 individuals: Providing detailed number needed to scope (NNS) before colonoscopy. Medicine (Baltimore) 2016; 95:e4414. [PMID: 27603337 PMCID: PMC5023859 DOI: 10.1097/md.0000000000004414] [Citation(s) in RCA: 12] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/29/2023] Open
Abstract
The fecal immunochemical test (FIT) is underutilized, in part, because its benefits have not been fully understood. We assessed the relationship of FIT values with cancer incidence and mortality, and explored how repeated administrations of FIT could aid clinicians. A cohort with 513,283 adults in Taiwan participated in a screening program between 1994 and the end of 2007. Colorectal cancer was identified from National Cancer Registry and not from colonoscopy. Positive FIT was FIT ≥ 100 ng/mL. Number needed to scope (NNS) to identify 1 cancer by different FIT values was calculated for the study time. Only 4% of subjects had FIT ≥ 100 ng/mL but contributed 40% of cancer cases, leading to a NNS of 25 for finding 1 in this group. However, within the same FIT ≥ 100 ng/mL, NNS was different by age: 10 for age 60 to 69 years, 42 for age 40 to 49 years, and 156 for age 20 to 39 years. Furthermore, within the same age, NNS was different by FIT values, for instance, 66 for FIT 100 to 199 ng/mL and 12 for FIT 600 to 799 ng/mL, a difference of 5-fold for age 50 to 59 years. The dose-response relationship of FIT can facilitate consultation regarding the need for colonoscopy by providing a quantitative NNS for cancer risk, an index easily understood by patients. Our conclusion made use of (a) age-dependent and (b) quantitative interpretation of FIT values. This single cutpoint practice obliterates a large amount of valuable cancer risk information available to patients.
Collapse
Affiliation(s)
- Chien Hua Chen
- Digestive Disease Center, Show-Chwan Memorial Hospital, Changhua
- Chung Chou University of Science and Technology, Changhua
- Hungkuang University, Taichung
| | - Chi Pang Wen
- Institute of Population Health Sciences, National Health Research Institutes, Zhunan
- China Medical University, Taichung, Taiwan
- Correspondence: Chi Pang Wen, China Medical University Hospital, 91 Hsueh-Shih Road Taichung 40402, Taiwan and Institute of Population Health Sciences, National Health Research Institutes, 35 Keyan Road, Zhunan Town, Miaoli County 35053, Taiwan (e-mail: )
| | - Min Kuang Tsai
- Institute of Population Health Sciences, National Health Research Institutes, Zhunan
- China Medical University, Taichung, Taiwan
| |
Collapse
|
|
27
|
Comparison of the yield from two faecal immunochemical tests at identical cutoff concentrations - a randomized trial in Latvia. Eur J Gastroenterol Hepatol 2016; 28:904-10. [PMID: 27120388 DOI: 10.1097/meg.0000000000000650] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/31/2022]
Abstract
OBJECTIVE We have compared the performance of two faecal immunochemical tests (FIT) in an average-risk population. MATERIALS AND METHODS Altogether, 10 000 individuals aged 50-74 were selected randomly from the population of Latvia in 2011 and assigned randomly either to OC-Sensor or to FOB Gold single-time testing. Positivity of the test, frequency of colonic lesions, number needed to screen (NNscreen) and scope for the detection of an advanced neoplasm (cancer and advanced adenoma) were compared between the tests using the same cutoff concentrations in µg/g faeces. Confidence intervals (CIs) at 95% were calculated. RESULTS Positivity with the cutoff set at 10 µg/g faeces was 12.8% (95% CI: 11.4-14.2) for FOB Gold and 8.3% (95% CI: 7.2-9.4) for OC-Sensor (P<0.001). Positivity was higher in men and the older age groups. Colonoscopy compliance was 55.5%. There was no significant difference between the two tests at comparable cutoff concentrations in µg/g, colonoscopy attendance rate or colonoscopy results. For advanced neoplasm detection, there was no significant difference in number needed to scope and NNscreen at a cutoff of 10 µg/g faeces; however, lower NNscreen was required to detect advanced neoplasms with the FOB Gold test at increased cutoff concentrations. CONCLUSION Different quantitative FIT systems may report different positivity rate at identical cutoff concentrations, which has to be considered when implementing the use of FIT in national screening programmes.
Collapse
|
|
28
|
Juul JS, Bro F, Hornung N, Andersen BS, Laurberg S, Olesen F, Vedsted P. Implementation of immunochemical faecal occult blood test in general practice: a study protocol using a cluster-randomised stepped-wedge design. BMC Cancer 2016; 16:445. [PMID: 27400657 PMCID: PMC4940713 DOI: 10.1186/s12885-016-2477-9] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/25/2016] [Accepted: 06/30/2016] [Indexed: 02/06/2023] Open
Abstract
BACKGROUND Colorectal cancer is a common malignancy and a leading cause of cancer-related death. Half of patients with colorectal cancer initially present with non-specific or vague symptoms. In the need for a safe low-cost test, the immunochemical faecal occult blood test (iFOBT) may be part of the evaluation of such patients in primary care. Currently, Danish general practitioners have limited access to this test. The aim of this article is to describe a study that will assess the uptake and clinical use of iFOBT in general practice. Furthermore, it will investigate the diagnostic value and the clinical implications of using iFOBT in general practice on patients presenting with non-alarm symptoms of colorectal cancer. METHODS/DESIGN The study uses a cluster-randomised stepped-wedge design and is conducted in the Central Denmark Region among 836 GPs in 381 general practices. The municipalities of the Region and their appertaining general practitioners will be included sequentially in the study during the first 7 months of the 1-year study period. The following intervention has been developed for the study: a mandatory intervention providing all general practitioners with a starting package of 10 iFOBTs, a clinical instruction on iFOBT use in general practice and online information material from the date of inclusion, and an optional intervention consisting of a continuous medical education on colorectal cancer diagnostics and use of iFOBT. DISCUSSION This study is among the first and largest trials to investigate the diagnostic use and the clinical value of iFOBT on patients presenting with non-alarm symptoms of colorectal cancer. The findings will be of national and international importance for the future planning of colorectal cancer diagnostics, particularly for 'low-risk-but-not-no-risk' patients with non-alarm symptoms of colorectal cancer. TRIAL REGISTRATION A Trial of the Implementation of iFOBT in General Practice NCT02308384 . Date of registration: 26 November 2014.
Collapse
Affiliation(s)
- Jakob Søgaard Juul
- Research Unit for General Practice, Department of Public Health, Aarhus University, Bartholins Allé 2, 8000, Aarhus C, Denmark. .,Research Centre for Cancer Diagnosis in Primary Care, Department of Public Health, Aarhus University, Bartholins Allé 2, 8000, Aarhus C, Denmark.
| | - Flemming Bro
- Research Unit for General Practice, Department of Public Health, Aarhus University, Bartholins Allé 2, 8000, Aarhus C, Denmark
| | - Nete Hornung
- Department of Clinical Biochemistry, Regional Hospital of Randers, Skovlyvej 1, 8930, Randers NE, Denmark
| | - Berit Sanne Andersen
- Department of Public Health Programs, Regional Hospital of Randers, Skovlyvej 1, 8930, Randers NE, Denmark
| | - Søren Laurberg
- Department of Surgery, Aarhus University Hospital, Tage Hansens Gade 2, 8000, Aarhus C, Denmark
| | - Frede Olesen
- Research Unit for General Practice, Department of Public Health, Aarhus University, Bartholins Allé 2, 8000, Aarhus C, Denmark
| | - Peter Vedsted
- Research Unit for General Practice, Department of Public Health, Aarhus University, Bartholins Allé 2, 8000, Aarhus C, Denmark.,Research Centre for Cancer Diagnosis in Primary Care, Department of Public Health, Aarhus University, Bartholins Allé 2, 8000, Aarhus C, Denmark
| |
Collapse
|
|
29
|
Alvarez-Urturi C, Andreu M, Hernandez C, Perez-Riquelme F, Carballo F, Ono A, Cruzado J, Cubiella J, Hernandez V, Mao CG, Perez E, Salas D, Andrés M, Bujanda L, Portillo I, Sarasqueta C, Quintero E, Morillas JD, Lanas A, Sostres C, Augé JM, Castells A, Bessa X. Impact of age- and gender-specific cut-off values for the fecal immunochemical test for hemoglobin in colorectal cancer screening. Dig Liver Dis 2016; 48:542-551. [PMID: 26936343 DOI: 10.1016/j.dld.2016.02.001] [Citation(s) in RCA: 21] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/19/2015] [Revised: 01/15/2016] [Accepted: 02/01/2016] [Indexed: 12/11/2022]
Abstract
BACKGROUND There is no information on the impact of age and gender on the diagnostic yield of different positivity thresholds for the fecal immunochemical test for hemoglobin (FIT). OBJECTIVES To evaluate the performance of this test at distinct positivity cut-offs in a population-based colorectal cancer (CRC) screening program. METHODS CRC detection rate (DR), and analysis of resources were evaluated retrospectively, at different cut-offs of FIT (20, 25, 30, 35 and 40μg Hb/g) respect to a reference value (15μg Hb/g), according to age and gender, in a screening population of 10,611 participants of the ColonPrev study (Quintero. NEJM 2013). RESULTS At the reference cut-off value, 36 CRC and 252 advanced adenomas (AA) were diagnosed. Increasing the cut-off in women ≤60 years decreases colonoscopies performed by 44.5% without modifying the CRC (DR). Same CRC DR was observed in men ≤60 years and women >60 years increasing cut-off at 25-30μg Hb/g. In men >60 years, all increases in the cut-off affected the CRC DR, especially when the cut-off was increased from 35 to 40μg Hb/g (CRC miss rate 25%). CONCLUSIONS To improve the performance of FIT in CRC screening programs, FIT cut-offs could be individualized by age and gender.
Collapse
Affiliation(s)
- Cristina Alvarez-Urturi
- Department of Gastroenterology, Hospital del Mar, Cancer Research Program, IMIM (Hospital del Mar Medical Research Institute), Autonomous University of Barcelona and Pompeu Fabra University, Barcelona, Catalonia, Spain
| | - Montserrat Andreu
- Department of Gastroenterology, Hospital del Mar, Cancer Research Program, IMIM (Hospital del Mar Medical Research Institute), Autonomous University of Barcelona and Pompeu Fabra University, Barcelona, Catalonia, Spain
| | - Cristina Hernandez
- Department of Epidemiology and Evaluation, Hospital del Mar, IMIM (Hospital del Mar Medical Research Institute), Barcelona, Catalonia, Spain
| | - Francisco Perez-Riquelme
- Colorectal Cancer Prevention Program of Murcia, Dirección General de Salud Pública, Consejería de Sanidad y Política Social, Murcia, Spain
| | - Fernando Carballo
- Colorectal Cancer Prevention Program of Murcia, Dirección General de Salud Pública, Consejería de Sanidad y Política Social, Murcia, Spain
| | - Akiko Ono
- Colorectal Cancer Prevention Program of Murcia, Dirección General de Salud Pública, Consejería de Sanidad y Política Social, Murcia, Spain
| | - Jose Cruzado
- Colorectal Cancer Prevention Program of Murcia, Dirección General de Salud Pública, Consejería de Sanidad y Política Social, Murcia, Spain
| | - Joaquín Cubiella
- Department of Gastroenterology, Complexo Hospitalario Universitario de Ourense, IBIV - Institute of Biomedical Research of Vigo, Vigo, Spain
| | - Vicent Hernandez
- Department of Gastroenterology, Complexo Hospitalario Universitario de Ourense, IBIV - Institute of Biomedical Research of Vigo, Vigo, Spain
| | | | - Elena Perez
- Colorectal Cancer Screening Program, Dirección General de Salud Pública, València, Spain
| | - Dolores Salas
- Colorectal Cancer Screening Program, Dirección General de Salud Pública, València, Spain
| | - Mercedes Andrés
- Colorectal Cancer Screening Program, Dirección General de Salud Pública, València, Spain
| | - Luis Bujanda
- Department of Gastroenterology, Donostia Hospital-Instituto Biodonostia, CIBERehd, University of Basque Country (UPV/EHU), San Sebastián, Spain
| | - Isabel Portillo
- Centro Coordinador del Programa de Cribado Cáncer Colorrectal, Organización Central de Osakidetza-Servicio Vasco de Salud, San Sebastián, Spain
| | - Cristina Sarasqueta
- Hospital Donostia, Red de Investigación en Servicios de Salud en Enfermedades Crónicas (REDISSEC), San Sebastián, Spain
| | - Enrique Quintero
- Department of Gastroenterology, Hospital Universitario de Canarias, San Cristóbal de La Laguna, Santa Cruz de Tenerife, Spain
| | | | - Angel Lanas
- Department of Gastroenterology, University of Zaragoza, IIS Aragón, CIBERehd, Zaragoza, Spain
| | - Carlos Sostres
- Department of Gastroenterology, University of Zaragoza, IIS Aragón, CIBERehd, Zaragoza, Spain
| | - Josep Maria Augé
- Department of Biochemistry and Molecular Genetics, Hospital Clinic, IDIBAPS, University of Barcelona, Barcelona, Catalonia, Spain
| | - Antoni Castells
- Department of Gastroenterology, Hospital Clínic, Centro de Investigación Biomédica en Red en Enfermedades Hepáticas y Digestivas (CIBERehd), IDIBAPS, University of Barcelona, Barcelona, Catalonia, Spain
| | - Xavier Bessa
- Department of Gastroenterology, Hospital del Mar, Cancer Research Program, IMIM (Hospital del Mar Medical Research Institute), Autonomous University of Barcelona and Pompeu Fabra University, Barcelona, Catalonia, Spain.
| |
Collapse
|
|
30
|
Crouse AL, De Koning L, Sadrzadeh SMH, Naugler C. Sensitivity and Specificity of Community Fecal Immunotesting Screening for Colorectal Carcinoma in a High-Risk Canadian Population. Arch Pathol Lab Med 2016; 139:1441-5. [PMID: 26516941 DOI: 10.5858/arpa.2014-0454-oa] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/06/2022]
Abstract
CONTEXT Community-based programs are a common way of promoting colorectal cancer screening by primary care physicians. Fecal immunochemical testing (FIT) is a screening method commonly used in such programs. Fecal immunochemical testing has advantages to the patient as well as to clinical laboratories. OBJECTIVE To assess the operational test characteristics of a FIT pilot program in Calgary, Alberta, Canada, between April 2011 and May 2012. DESIGN Four hundred fifty-seven high-risk patients undergoing both FIT and colonoscopy were included. Areas under the curve and positive predictive values were derived for FIT values and biopsy-proven neoplasia. Subgroup analysis was also performed on men and women and for ages older and younger than the mean age of 62 years. RESULTS For colorectal carcinoma and colonic adenomas the areas under the curve were 0.79 (95% confidence interval 0.71-0.87) and 0.60 (95% confidence interval 0.54-0.65), respectively. The positive predictive value of a positive FIT result for any neoplasia was 53%. The overall performance of the test for all neoplasia was better for men and better for older individuals. CONCLUSIONS The performance of FIT in this clinical setting was very good for detecting carcinoma, but marginal for detection of colonic adenomas.
Collapse
Affiliation(s)
| | | | | | - Christopher Naugler
- From Calgary Laboratory Services, Calgary, Alberta, Canada (Ms Crouse and Drs Koning, Sadrzadeh, and Naugler); and the Departments of Pathology and Laboratory Medicine (Ms Crouse and Drs Koning, Sadrzadeh, and Naugler) and Family Medicine (Dr Naugler), University of Calgary, Calgary, Alberta, Canada
| |
Collapse
|
|
31
|
|
|
32
|
Sali L, Mascalchi M, Falchini M, Ventura L, Carozzi F, Castiglione G, Delsanto S, Mallardi B, Mantellini P, Milani S, Zappa M, Grazzini G. Reduced and Full-Preparation CT Colonography, Fecal Immunochemical Test, and Colonoscopy for Population Screening of Colorectal Cancer: A Randomized Trial. J Natl Cancer Inst 2016; 108:djv319. [PMID: 26719225 DOI: 10.1093/jnci/djv319] [Citation(s) in RCA: 67] [Impact Index Per Article: 7.4] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/15/2015] [Accepted: 10/05/2015] [Indexed: 12/20/2022] Open
Abstract
BACKGROUND Population screening for colorectal cancer (CRC) is widely adopted, but the preferred strategy is still under debate. We aimed to compare reduced (r-CTC) and full cathartic preparation CT colonography (f-CTC), fecal immunochemical test (FIT), and optical colonoscopy (OC) as primary screening tests for CRC. METHODS Citizens of a district of Florence, Italy, age 54 to 65 years, were allocated (8:2.5:2.5:1) with simple randomization to be invited by mail to one of four screening interventions: 1) biennial FIT for three rounds, 2) r-CTC, 3) f-CTC, 4) OC. Patients tested positive to FIT or CTC (at least one polyp ≥6mm) were referred to OC work-up. The primary outcomes were participation rate and detection rate (DR) for cancer or advanced adenoma (advanced neoplasia). All statistical tests were two-sided. RESULTS Sixteen thousand eighty-seven randomly assigned subjects were invited to the assigned screening test. Participation rates were 50.4% (4677/9288) for first-round FIT, 28.1% (674/2395) for r-CTC, 25.2% (612/2430) for f-CTC, and 14.8% (153/1036) for OC. All differences between groups were statistically significant (P = .047 for r-CTC vs f-CTC; P < .001 for all others). DRs for advanced neoplasia were 1.7% (79/4677) for first-round FIT, 5.5% (37/674) for r-CTC, 4.9% (30/612) for f-CTC, and 7.2% (11/153) for OC. Differences in DR between CTC groups and FIT were statistically significant (P < .001), but not between r-CTC and f-CTC (P = .65). CONCLUSIONS Reduced preparation increases participation in CTC. Lower attendance and higher DR of CTC as compared with FIT are key factors for the optimization of its role in population screening of CRC.
Collapse
Affiliation(s)
- Lapo Sali
- Department of Biomedical, Experimental and Clinical Sciences 'Mario Serio', University of Florence, Florence, Italy (LS, MM, MF, SM); Cancer Prevention and Research Institute (ISPO), Florence, Italy (LV, FC, GC, BM, PM, MZ, GG); im3D S.p.A., Turin, Italy (SD).
| | - Mario Mascalchi
- Department of Biomedical, Experimental and Clinical Sciences 'Mario Serio', University of Florence, Florence, Italy (LS, MM, MF, SM); Cancer Prevention and Research Institute (ISPO), Florence, Italy (LV, FC, GC, BM, PM, MZ, GG); im3D S.p.A., Turin, Italy (SD)
| | - Massimo Falchini
- Department of Biomedical, Experimental and Clinical Sciences 'Mario Serio', University of Florence, Florence, Italy (LS, MM, MF, SM); Cancer Prevention and Research Institute (ISPO), Florence, Italy (LV, FC, GC, BM, PM, MZ, GG); im3D S.p.A., Turin, Italy (SD)
| | - Leonardo Ventura
- Department of Biomedical, Experimental and Clinical Sciences 'Mario Serio', University of Florence, Florence, Italy (LS, MM, MF, SM); Cancer Prevention and Research Institute (ISPO), Florence, Italy (LV, FC, GC, BM, PM, MZ, GG); im3D S.p.A., Turin, Italy (SD)
| | - Francesca Carozzi
- Department of Biomedical, Experimental and Clinical Sciences 'Mario Serio', University of Florence, Florence, Italy (LS, MM, MF, SM); Cancer Prevention and Research Institute (ISPO), Florence, Italy (LV, FC, GC, BM, PM, MZ, GG); im3D S.p.A., Turin, Italy (SD)
| | - Guido Castiglione
- Department of Biomedical, Experimental and Clinical Sciences 'Mario Serio', University of Florence, Florence, Italy (LS, MM, MF, SM); Cancer Prevention and Research Institute (ISPO), Florence, Italy (LV, FC, GC, BM, PM, MZ, GG); im3D S.p.A., Turin, Italy (SD)
| | - Silvia Delsanto
- Department of Biomedical, Experimental and Clinical Sciences 'Mario Serio', University of Florence, Florence, Italy (LS, MM, MF, SM); Cancer Prevention and Research Institute (ISPO), Florence, Italy (LV, FC, GC, BM, PM, MZ, GG); im3D S.p.A., Turin, Italy (SD)
| | - Beatrice Mallardi
- Department of Biomedical, Experimental and Clinical Sciences 'Mario Serio', University of Florence, Florence, Italy (LS, MM, MF, SM); Cancer Prevention and Research Institute (ISPO), Florence, Italy (LV, FC, GC, BM, PM, MZ, GG); im3D S.p.A., Turin, Italy (SD)
| | - Paola Mantellini
- Department of Biomedical, Experimental and Clinical Sciences 'Mario Serio', University of Florence, Florence, Italy (LS, MM, MF, SM); Cancer Prevention and Research Institute (ISPO), Florence, Italy (LV, FC, GC, BM, PM, MZ, GG); im3D S.p.A., Turin, Italy (SD)
| | - Stefano Milani
- Department of Biomedical, Experimental and Clinical Sciences 'Mario Serio', University of Florence, Florence, Italy (LS, MM, MF, SM); Cancer Prevention and Research Institute (ISPO), Florence, Italy (LV, FC, GC, BM, PM, MZ, GG); im3D S.p.A., Turin, Italy (SD)
| | - Marco Zappa
- Department of Biomedical, Experimental and Clinical Sciences 'Mario Serio', University of Florence, Florence, Italy (LS, MM, MF, SM); Cancer Prevention and Research Institute (ISPO), Florence, Italy (LV, FC, GC, BM, PM, MZ, GG); im3D S.p.A., Turin, Italy (SD)
| | - Grazia Grazzini
- Department of Biomedical, Experimental and Clinical Sciences 'Mario Serio', University of Florence, Florence, Italy (LS, MM, MF, SM); Cancer Prevention and Research Institute (ISPO), Florence, Italy (LV, FC, GC, BM, PM, MZ, GG); im3D S.p.A., Turin, Italy (SD)
| |
Collapse
|
|
33
|
Gwede CK, Koskan AM, Quinn GP, Davis SN, Ealey J, Abdulla R, Vadaparampil ST, Elliott G, Lopez D, Shibata D, Roetzheim RG, Meade CD. Patients' perceptions of colorectal cancer screening tests and preparatory education in federally qualified health centers. JOURNAL OF CANCER EDUCATION : THE OFFICIAL JOURNAL OF THE AMERICAN ASSOCIATION FOR CANCER EDUCATION 2015; 30:294-300. [PMID: 25249181 PMCID: PMC4372499 DOI: 10.1007/s13187-014-0733-8] [Citation(s) in RCA: 17] [Impact Index Per Article: 1.7] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 05/27/2023]
Abstract
This study explored federally qualified health center (FQHC) patients' perceptions about colorectal cancer screening (CRCS) tests, including immunochemical fecal occult blood tests (iFOBT), as well as preferences for receiving in-clinic education about CRCS. Eight mixed gender focus groups were conducted with 53 patients. Findings centered on three thematic factors: (1) motivators and impediments to CRCS, (2) test-specific preferences and receptivity to iFOBTs, and (3) preferences for entertaining and engaging plain language materials. Results informed the development of educational priming materials to increase CRCS using iFOBT in FQHCs.
Collapse
Affiliation(s)
- Clement K Gwede
- Division of Cancer Prevention and Control, Moffitt Cancer Center, 12902 Magnolia Drive, MRC-CANCONT, Tampa, FL, 33612, USA,
| | | | | | | | | | | | | | | | | | | | | | | |
Collapse
|
|
34
|
Fenocchi E, Gaggero P, Rondán M, López-Alvarenga JC, Sobrino-Cossío S, Lambert N, Eishi Y. Usefulness of the fecal immunochemical test in the detection of advanced adenomas in subjects at average risk for colorectal cancer. ENDOSCOPIA 2015. [DOI: 10.1016/j.endomx.2015.07.002] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 10/23/2022]
|
|
35
|
|
|
36
|
Quintero E, Carrillo M, Gimeno-García AZ, Hernández-Guerra M, Nicolás-Pérez D, Alonso-Abreu I, Díez-Fuentes ML, Abraira V. Equivalency of fecal immunochemical tests and colonoscopy in familial colorectal cancer screening. Gastroenterology 2014; 147:1021-30.e1; quiz e16-7. [PMID: 25127679 DOI: 10.1053/j.gastro.2014.08.004] [Citation(s) in RCA: 42] [Impact Index Per Article: 3.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/12/2014] [Revised: 08/05/2014] [Accepted: 08/09/2014] [Indexed: 12/17/2022]
Abstract
BACKGROUND & AIMS Colonoscopy is the recommended screening procedure for first-degree relatives of patients with colorectal cancer (CRC), but few studies have compared its efficacy for CRC detection with that of other screening strategies. We conducted a controlled randomized trial to compare the efficacy of repeated fecal immunochemical tests (FITs) and colonoscopy in detecting advanced neoplasia (advanced adenoma or CRC) in family members of patients with CRC. METHODS In a prospective study, 1918 first-degree relatives of patients with CRC were randomly assigned (1:1 ratio) to receive a single colonoscopy examination or 3 FITs (1/year for 3 years; OC-Sensor; cutoff ≥10 μg hemoglobin/g feces, corresponding to 50 ng hemoglobin/mL buffer). The strategies were considered to be equivalent if the 95% confidence interval of the difference for the detection of advanced neoplasia was ±3%. Follow-up analyses were performed to identify false-negative FIT results and interval CRCs. RESULTS Of all eligible asymptomatic first-degree relatives, 782 were included in the colonoscopy group and 784 in the FIT group. In the intention-to-screen analysis, advanced neoplasia was detected in 33 (4.2%) and 44 (5.6%) first-degree relatives in the FIT and colonoscopy groups, respectively (odds ratio = 1.41; 95% confidence interval: 0.88-2.26; P = .14). In the per-protocol analysis, 28 first-degree relatives (3.9%) in the FIT group and 43 (5.8%) in the colonoscopy group had advanced neoplasia (odds ratio = 1.56; 95% confidence interval: 0.95-2.56; P = .08). FIT missed 16 of 41 advanced adenomas but no CRCs. The FIT strategy required endoscopic evaluation of 4-fold fewer individuals to detect 1 advanced neoplasia than the colonoscopy strategy. CONCLUSIONS Repeated FIT screening (1/year for 3 years) detected all CRCs and proved equivalent to colonoscopy in detecting advanced neoplasia in first-degree relatives of patients with CRC. This strategy should be considered for populations where compliance with FITs is higher than with colonoscopy. ClinicalTrials.gov number: NCT01075633 (COLONFAM Study).
Collapse
Affiliation(s)
- Enrique Quintero
- Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB) and Centro de Investigación Biomédica de Canarias (CIBICAN), Departamento de Medicina Interna, Universidad de La Laguna, La Laguna, Tenerife, Spain.
| | - Marta Carrillo
- Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB) and Centro de Investigación Biomédica de Canarias (CIBICAN), Departamento de Medicina Interna, Universidad de La Laguna, La Laguna, Tenerife, Spain
| | - Antonio Z Gimeno-García
- Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB) and Centro de Investigación Biomédica de Canarias (CIBICAN), Departamento de Medicina Interna, Universidad de La Laguna, La Laguna, Tenerife, Spain
| | - Manuel Hernández-Guerra
- Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB) and Centro de Investigación Biomédica de Canarias (CIBICAN), Departamento de Medicina Interna, Universidad de La Laguna, La Laguna, Tenerife, Spain
| | - David Nicolás-Pérez
- Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB) and Centro de Investigación Biomédica de Canarias (CIBICAN), Departamento de Medicina Interna, Universidad de La Laguna, La Laguna, Tenerife, Spain
| | - Inmaculada Alonso-Abreu
- Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB) and Centro de Investigación Biomédica de Canarias (CIBICAN), Departamento de Medicina Interna, Universidad de La Laguna, La Laguna, Tenerife, Spain
| | | | - Víctor Abraira
- Unidad de Bioestadística Clínica, Hospital Universitario Ramón y Cajal, IRYCIS, Madrid, Spain; CIBER Epidemiología y Salud Pública (CIBERESP), Barcelona, Spain
| |
Collapse
|
|
37
|
Chausserie S, Levillain R, Puvinel J, Ferrand O, Ruiz A, Raginel T, Lantieri O, Launoy G, Guittet L. Seasonal variations do not affect the superiority of fecal immunochemical tests over guaiac tests for colorectal cancer screening. Int J Cancer 2014; 136:1827-34. [DOI: 10.1002/ijc.29187] [Citation(s) in RCA: 14] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/26/2013] [Revised: 08/06/2014] [Accepted: 08/12/2014] [Indexed: 12/18/2022]
Affiliation(s)
- Sébastien Chausserie
- Centre Hospitalier Universitaire (CHU) de Caen, Evaluations et recherches en épidémiologie; Caen
- Normandie University; Caen
- Université de Caen Basse-Normandie (UCBN), Cancers and Preventions; Caen
- INSERM U1086, Cancers and preventions; Caen
| | - Romuald Levillain
- Institut InterRégional pour la Santé (IRSA) de Tours, Centre de lecture des tests de recherche de sang dans les selles; La Riche France
| | - Josette Puvinel
- Association Bourbonnaise Interdépartementale de Dépistage des Cancers (ABIDEC); Moulins
| | - Olivier Ferrand
- Action de Dépistage Organisé des Cancers 18 (ADOC18); Saint-Doulchard
| | - Angela Ruiz
- Institut InterRégional pour la Santé (IRSA) de Tours, Centre de lecture des tests de recherche de sang dans les selles; La Riche France
| | - Thibaut Raginel
- Centre Hospitalier Universitaire (CHU) de Caen, Evaluations et recherches en épidémiologie; Caen
- Normandie University; Caen
- Université de Caen Basse-Normandie (UCBN), Cancers and Preventions; Caen
- INSERM U1086, Cancers and preventions; Caen
| | - Olivier Lantieri
- Institut InterRégional pour la Santé (IRSA) de Tours, Centre de lecture des tests de recherche de sang dans les selles; La Riche France
| | - Guy Launoy
- Centre Hospitalier Universitaire (CHU) de Caen, Evaluations et recherches en épidémiologie; Caen
- Normandie University; Caen
- Université de Caen Basse-Normandie (UCBN), Cancers and Preventions; Caen
- INSERM U1086, Cancers and preventions; Caen
| | - Lydia Guittet
- Centre Hospitalier Universitaire (CHU) de Caen, Evaluations et recherches en épidémiologie; Caen
- Normandie University; Caen
- Université de Caen Basse-Normandie (UCBN), Cancers and Preventions; Caen
- INSERM U1086, Cancers and preventions; Caen
| |
Collapse
|
|
38
|
Auge JM, Pellise M, Escudero JM, Hernandez C, Andreu M, Grau J, Buron A, López-Cerón M, Bessa X, Serradesanferm A, Piracés M, Macià F, Guayta R, Filella X, Molina R, Jimenez W, Castells A. Risk stratification for advanced colorectal neoplasia according to fecal hemoglobin concentration in a colorectal cancer screening program. Gastroenterology 2014; 147:628-636.e1. [PMID: 24937264 DOI: 10.1053/j.gastro.2014.06.008] [Citation(s) in RCA: 86] [Impact Index Per Article: 7.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/15/2014] [Revised: 06/04/2014] [Accepted: 06/05/2014] [Indexed: 02/07/2023]
Abstract
BACKGROUND & AIMS The latest generation of fecal immunochemical tests (FIT) allows for quantitation of hemoglobin in feces, allowing for selection of optimal cut-off concentrations. We investigated whether individuals with positive results from quantitative FITs, in combination with other factors, could be identified as being at greatest risk for advanced colorectal neoplasia. METHODS In a retrospective study, we analyzed data from a consecutive series of 3109 participants with positive results from FITs (≥20 μg/g of feces) included in the first round of the Barcelona colorectal cancer screening program, from December 2009 through February 2012. All participants underwent colonoscopy and were assigned to groups with any advanced colorectal neoplasia or with nonadvanced colorectal neoplasia (but with another diagnosis or normal examination findings). RESULTS Median fecal hemoglobin concentrations were significantly higher in participants with advanced colorectal neoplasia (105 μg/g; interquartile range, 38-288 μg/g) compared with participants with nonadvanced colorectal neoplasia (47 μg/g; interquartile range, 23-119 μg/g) (P < .001). Positive predictive values for advanced colorectal neoplasia, determined using arbitrary fecal hemoglobin concentrations, differed with sex and age. Multivariate logistic regression analysis identified sex (men: odds ratio [OR], 2.07; 95% confidence interval, 1.78-2.41), age (60-69 y: OR, 1.24; 95% confidence interval, 1.07-1.44), and fecal hemoglobin concentration (>177 μg/g: OR, 3.80; 95% confidence interval, 3.07-4.71) as independent predictive factors for advanced colorectal neoplasia. Combining these factors, we identified 16 risk categories associated with different probabilities of identifying advanced colorectal neoplasia. Risk for advanced colorectal neoplasia increased 11.46-fold among individuals in the highest category compared with the lowest category; positive predictive values ranged from 21.3% to 75.6%. CONCLUSIONS Fecal hemoglobin concentration, in addition to sex and age, in individuals with positive results from FITs can be used to stratify probability for the detection of advanced colorectal neoplasia. These factors should be used to prioritize individuals for colonoscopy examination.
Collapse
Affiliation(s)
- Josep M Auge
- Biochemistry and Molecular Genetics Department, Hospital Clínic, Barcelona, Spain.
| | - Maria Pellise
- Gastroenterology Department, Hospital Clínic, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Centro de Investigación Biomédica en Red en el Área temática de Enfermedades Hepáticas y Digestivas (CIBERehd), University of Barcelona, Barcelona, Spain
| | - José M Escudero
- Biochemistry and Molecular Genetics Department, Hospital Clínic, Barcelona, Spain
| | - Cristina Hernandez
- Epidemiology and Evaluation Department, Hospital del Mar, Barcelona, Spain
| | | | - Jaume Grau
- Preventive Medicine and Hospital Epidemiology Department, Hospital Clinic, University of Barcelona, Barcelona, Spain
| | - Andrea Buron
- Epidemiology and Evaluation Department, Hospital del Mar, Barcelona, Spain
| | - María López-Cerón
- Gastroenterology Department, Hospital Clínic, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Centro de Investigación Biomédica en Red en el Área temática de Enfermedades Hepáticas y Digestivas (CIBERehd), University of Barcelona, Barcelona, Spain
| | - Xavier Bessa
- Gastroenterology Department, Hospital del Mar, Barcelona, Spain
| | - Anna Serradesanferm
- Preventive Medicine and Hospital Epidemiology Department, Hospital Clinic, University of Barcelona, Barcelona, Spain
| | - Mercè Piracés
- Epidemiology and Evaluation Department, Hospital del Mar, Barcelona, Spain
| | - Francesc Macià
- Epidemiology and Evaluation Department, Hospital del Mar, Barcelona, Spain
| | - Rafael Guayta
- Council of Colleges of Pharmacists in Catalonia, Barcelona, Spain
| | - Xavier Filella
- Biochemistry and Molecular Genetics Department, Hospital Clínic, Barcelona, Spain
| | - Rafael Molina
- Biochemistry and Molecular Genetics Department, Hospital Clínic, Barcelona, Spain
| | - Wladimiro Jimenez
- Biochemistry and Molecular Genetics Department, Hospital Clínic, Barcelona, Spain
| | - Antoni Castells
- Gastroenterology Department, Hospital Clínic, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Centro de Investigación Biomédica en Red en el Área temática de Enfermedades Hepáticas y Digestivas (CIBERehd), University of Barcelona, Barcelona, Spain
| | | |
Collapse
|
|
39
|
Steele RJ, McDonald PJ, Digby J, Brownlee L, Strachan JA, Libby G, McClements PL, Birrell J, Carey FA, Diament RH, Balsitis M, Fraser CG. Clinical outcomes using a faecal immunochemical test for haemoglobin as a first-line test in a national programme constrained by colonoscopy capacity. United European Gastroenterol J 2014; 1:198-205. [PMID: 24917960 DOI: 10.1177/2050640613489281] [Citation(s) in RCA: 66] [Impact Index Per Article: 6.0] [Reference Citation Analysis] [Abstract] [Key Words] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/29/2013] [Revised: 03/10/2013] [Accepted: 04/15/2013] [Indexed: 12/31/2022] Open
Abstract
INTRODUCTION Because of their many advantages, faecal immunochemical tests (FIT) are superseding traditional guaiac-based faecal occult blood tests in bowel screening programmes. METHODS A quantitative FIT was adopted for use in two evaluation National Health Service (NHS) Boards in Scotland using a cut-off faecal haemoglobin concentration chosen to give a positivity rate equivalent to that achieved in the Scottish Bowel Screening Programme. Uptake and clinical outcomes were compared with results obtained contemporaneously in two other similar NHS Boards and before and after the evaluation in the two evaluation NHS Boards. RESULTS During the evaluation, uptake was 58.5%. This was higher than in the same NHS Boards both before and after the evaluation, higher than in the other two NHS Boards and higher than the 53.7% achieved overall in Scotland. The overall positivity rate was higher in men than in women and increased with age in both genders. Positive predictive values for cancer (4.8%), high-risk adenoma (23.3%), all adenoma (38.2%) and all neoplasia (43.0%) in the two test NHS Boards were similar in all groups. CONCLUSIONS In summary, this evaluation of the FIT supports the introduction of FIT as a first-line test, even when colonoscopy capacity is limited.
Collapse
Affiliation(s)
- Robert Jc Steele
- Department of Surgery, Ninewells Hospital and Medical School, Dundee, UK
| | | | - Jayne Digby
- Scottish Bowel Screening Centre, NHS Tayside, Dundee, UK
| | - Linda Brownlee
- Scottish Bowel Screening Centre, NHS Tayside, Dundee, UK
| | | | - Gillian Libby
- Scottish Bowel Screening Centre, NHS Tayside, Dundee, UK
| | - Paula L McClements
- Information Services Division, NHS National Services Scotland, Edinburgh, UK
| | - Janice Birrell
- National Services Division, NHS National Services Scotland, Edinburgh, UK
| | - Francis A Carey
- Department of Pathology, Ninewells Hospital and Medical School, Dundee, UK
| | | | | | - Callum G Fraser
- Centre for Research into Cancer Prevention & Screening, Ninewells Hospital and Medical School, Dundee, UK
| |
Collapse
|
|
40
|
Yen AMF, Chen SLS, Chiu SYH, Fann JCY, Wang PE, Lin SC, Chen YD, Liao CS, Yeh YP, Lee YC, Chiu HM, Chen HH. A new insight into fecal hemoglobin concentration-dependent predictor for colorectal neoplasia. Int J Cancer 2014; 135:1203-12. [PMID: 24482014 DOI: 10.1002/ijc.28748] [Citation(s) in RCA: 26] [Impact Index Per Article: 2.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/23/2013] [Accepted: 01/09/2014] [Indexed: 12/31/2022]
Abstract
We sought to assess how much of the variation in incidence of colorectal neoplasia is explained by baseline fecal hemoglobin concentration (FHbC) and also to assess the additional predictive value of conventional risk factors. We enrolled subjects aged 40 years and over who attended screening for colorectal cancer with the fecal immunochemical test (FIT) in Keelung community-based integrated screening program. The accelerated failure time model was used to train the clinical weights of covariates in the prediction model. Datasets from two external communities were used for external validation. The area under curve (AUC) for the model containing only FHbC was 83.0% (95% CI: 81.5-84.4%), which was considerably greater than the one containing only conventional risk factors (65.8%, 95% CI: 64.2-67.4%). Adding conventional risk factors did not make significant additional contribution (p = 0.62, AUC = 83.5%, 95% CI: 82.1-84.9%) to the predictive model with FHbC only. Males showed a stronger linear dose-response relationship than females, yielding gender-specific FHbC predictive models. External validation confirms these results. The high predictive ability supported by a dose-dependent relationship between baseline FHbC and the risk of developing colorectal neoplasia suggests that FHbC may be useful for identifying cases requiring closer postdiagnosis clinical surveillance as well as being an early indicator of colorectal neoplasia risk in the general population. Our findings may also make contribution to the development of the FHbC-guided screening policy but its pros and cons in connection with cost and effectiveness of screening should be evaluated before it can be applied to population-based screening for colorectal cancer.
Collapse
Affiliation(s)
- Amy Ming-Fang Yen
- School of Oral Hygiene, College of Oral Medicine, Taipei Medical University, Taipei, Taiwan
| | | | | | | | | | | | | | | | | | | | | | | |
Collapse
|
|
41
|
Zubero MB, Arana-Arri E, Pijoan JI, Portillo I, Idigoras I, López-Urrutia A, Samper A, Uranga B, Rodríguez C, Bujanda L. Population-based colorectal cancer screening: comparison of two fecal occult blood test. Front Pharmacol 2014; 4:175. [PMID: 24454288 PMCID: PMC3887272 DOI: 10.3389/fphar.2013.00175] [Citation(s) in RCA: 26] [Impact Index Per Article: 2.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/22/2013] [Accepted: 12/20/2013] [Indexed: 12/31/2022] Open
Abstract
BACKGROUND The aim of screening for colorectal cancer is to improve prognosis by the detection of cancer at its early stages. In order to inform the decision on the specific test to be used in the population-based program in the Basque Autonomous Region (Spain), we compared two immunochemical fecal occult blood quantitative tests (I-FOBT). METHODS Residents of selected study areas, aged 50-69 years, were invited to participate in the screening. Two tests based on latex agglutination (OC-Sensor and FOB Gold) were randomly assigned to different study areas. A colonoscopy was offered to patients with a positive test result. The cut-off point used to classify a result as positive, according to manufacturer's recommendations, was 100 ng/ml for both tests. RESULTS The invited population included 37,999 individuals. Participation rates were 61.8% (n = 11,162) for OC-Sensor and 59.1% (n = 11,786) for FOB Gold (p = 0.008). Positive rate for OC-Sensor was 6.6% (n = 737) and 8.5% (n = 1,002) for FOB Gold (p < 0.0001). Error rates were higher for FOB gold (2.3%) than for OC-Sensor (0.2%; p < 0.0001). Predictive positive value (PPV) for total malignant and premalignant lesions was 62.4% for OC-Sensor and 58.9% for FOB Gold (p = 0.137), respectively. CONCLUSION OC-Sensor test appears to be superior for I-FOBT-based colorectal cancer screening, given its acceptance, ease of use, associated small number of errors and its screening accuracy. FOB Gold on the other hand, has higher rate of positive values, with more colonoscopies performed, it shows higher detection incidence rates, but involves more false positives.
Collapse
Affiliation(s)
- Miren B. Zubero
- Clinical Epidemiology Unit, Cruces University Hospital, Basque Health ServiceBarakaldo, Bizkaia, Spain
| | - Eunate Arana-Arri
- Clinical Epidemiology Unit, Cruces University Hospital, Basque Health ServiceBarakaldo, Bizkaia, Spain
- BioCruces Health Research InstituteBizkaia, Spain
| | - José I. Pijoan
- Clinical Epidemiology Unit, Cruces University Hospital, Basque Health ServiceBarakaldo, Bizkaia, Spain
- BioCruces Health Research InstituteBizkaia, Spain
- Biomedical Research Center Network for Epidemiology and Public HealthBizkaia, Spain
| | - Isabel Portillo
- Colorectal Cancer Screening Programme Coordinating Centre, Basque Health ServiceBizkaia, Spain
| | - Isabel Idigoras
- Colorectal Cancer Screening Programme Coordinating Centre, Basque Health ServiceBizkaia, Spain
| | - Antonio López-Urrutia
- Clinical Biochemistry Service, Cruces University Hospital, Basque Health ServiceBarakaldo, Bizkaia, Spain
| | - Ana Samper
- Clinical Biochemistry Service, Donostia University Hospital, Basque Health ServiceDonostia, Gipuzkoa, Spain
| | - Begoña Uranga
- Digestive Department, Donostia University Hospital, Basque Health ServiceDonostia, Gipuzkoa, Spain
| | - Carmen Rodríguez
- Clinical Biochemistry Service, Araba University Hospital, Basque Health ServiceGasteiz, Araba, Spain
| | - Luis Bujanda
- Digestive Department, Donostia University Hospital, Basque Health ServiceDonostia, Gipuzkoa, Spain
- Biodonostia Research InstituteDonostia, Spain
| |
Collapse
|
|
42
|
Zubero MB, Arana-Arri E, Pijoan JI, Portillo I, Idigoras I, López-Urrutia A, Samper A, Uranga B, Rodríguez C, Bujanda L. Population-based colorectal cancer screening: comparison of two fecal occult blood test. Front Pharmacol 2014. [PMID: 24454288 DOI: 10.3389/par.2013.00175] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Abstract] [Key Words] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/29/2022] Open
Abstract
BACKGROUND The aim of screening for colorectal cancer is to improve prognosis by the detection of cancer at its early stages. In order to inform the decision on the specific test to be used in the population-based program in the Basque Autonomous Region (Spain), we compared two immunochemical fecal occult blood quantitative tests (I-FOBT). METHODS Residents of selected study areas, aged 50-69 years, were invited to participate in the screening. Two tests based on latex agglutination (OC-Sensor and FOB Gold) were randomly assigned to different study areas. A colonoscopy was offered to patients with a positive test result. The cut-off point used to classify a result as positive, according to manufacturer's recommendations, was 100 ng/ml for both tests. RESULTS The invited population included 37,999 individuals. Participation rates were 61.8% (n = 11,162) for OC-Sensor and 59.1% (n = 11,786) for FOB Gold (p = 0.008). Positive rate for OC-Sensor was 6.6% (n = 737) and 8.5% (n = 1,002) for FOB Gold (p < 0.0001). Error rates were higher for FOB gold (2.3%) than for OC-Sensor (0.2%; p < 0.0001). Predictive positive value (PPV) for total malignant and premalignant lesions was 62.4% for OC-Sensor and 58.9% for FOB Gold (p = 0.137), respectively. CONCLUSION OC-Sensor test appears to be superior for I-FOBT-based colorectal cancer screening, given its acceptance, ease of use, associated small number of errors and its screening accuracy. FOB Gold on the other hand, has higher rate of positive values, with more colonoscopies performed, it shows higher detection incidence rates, but involves more false positives.
Collapse
Affiliation(s)
- Miren B Zubero
- Clinical Epidemiology Unit, Cruces University Hospital, Basque Health Service Barakaldo, Bizkaia, Spain
| | - Eunate Arana-Arri
- Clinical Epidemiology Unit, Cruces University Hospital, Basque Health Service Barakaldo, Bizkaia, Spain ; BioCruces Health Research Institute Bizkaia, Spain
| | - José I Pijoan
- Clinical Epidemiology Unit, Cruces University Hospital, Basque Health Service Barakaldo, Bizkaia, Spain ; BioCruces Health Research Institute Bizkaia, Spain ; Biomedical Research Center Network for Epidemiology and Public Health Bizkaia, Spain
| | - Isabel Portillo
- Colorectal Cancer Screening Programme Coordinating Centre, Basque Health Service Bizkaia, Spain
| | - Isabel Idigoras
- Colorectal Cancer Screening Programme Coordinating Centre, Basque Health Service Bizkaia, Spain
| | - Antonio López-Urrutia
- Clinical Biochemistry Service, Cruces University Hospital, Basque Health Service Barakaldo, Bizkaia, Spain
| | - Ana Samper
- Clinical Biochemistry Service, Donostia University Hospital, Basque Health Service Donostia, Gipuzkoa, Spain
| | - Begoña Uranga
- Digestive Department, Donostia University Hospital, Basque Health Service Donostia, Gipuzkoa, Spain
| | - Carmen Rodríguez
- Clinical Biochemistry Service, Araba University Hospital, Basque Health Service Gasteiz, Araba, Spain
| | - Luis Bujanda
- Digestive Department, Donostia University Hospital, Basque Health Service Donostia, Gipuzkoa, Spain ; Biodonostia Research Institute Donostia, Spain
| |
Collapse
|
|
43
|
Ventura L, Mantellini P, Grazzini G, Castiglione G, Buzzoni C, Rubeca T, Sacchettini C, Paci E, Zappa M. The impact of immunochemical faecal occult blood testing on colorectal cancer incidence. Dig Liver Dis 2014; 46:82-6. [PMID: 24011791 DOI: 10.1016/j.dld.2013.07.017] [Citation(s) in RCA: 102] [Impact Index Per Article: 9.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/15/2013] [Revised: 06/26/2013] [Accepted: 07/24/2013] [Indexed: 02/07/2023]
Abstract
BACKGROUND The efficacy of colorectal cancer screening based on faecal immunochemical test, in terms of reduction of colorectal cancer incidence, is under debate. In the district of Florence, an organized screening programme based on faecal immunochemical test has been running since the early 1990s. The aim of this study was to compare the risk of developing colorectal cancer for subjects undergoing faecal immunochemical test with those who did not undergo the test in the same period. METHODS Two cohorts were analyzed: subjects who underwent an initial faecal immunochemical test between 1993 and 1999 ("attenders"), and unscreened residents in the same municipalities invited to perform the faecal immunochemical test in the same period ("non-attenders"). Kaplan-Meier and Cox regression analysis were performed to evaluate the risk of developing colorectal cancer. RESULTS The attenders' and non-attenders' cohorts included 6961 and 26,285 subjects, respectively. Cox analysis showed a reduction in colorectal cancer incidence of 22% in the attenders' compared to the non-attenders' cohort (hazard ratio = 0.78, 95% Confidence Interval: 0.65-0.93). CONCLUSION Our results support the hypothesis that screening based on a single faecal immunochemical test every 2 years produces a significant decrease in colorectal cancer incidence after an average follow-up observation period of 11 years.
Collapse
Affiliation(s)
| | | | | | | | | | - Tiziana Rubeca
- Cancer Prevention and Research Institute, Florence, Italy
| | | | - Eugenio Paci
- Cancer Prevention and Research Institute, Florence, Italy
| | - Marco Zappa
- Cancer Prevention and Research Institute, Florence, Italy.
| |
Collapse
|
|
44
|
Lejeune C, Le Gleut K, Cottet V, Galimard C, Durand G, Dancourt V, Faivre J. The cost-effectiveness of immunochemical tests for colorectal cancer screening. Dig Liver Dis 2014; 46:76-81. [PMID: 24012177 DOI: 10.1016/j.dld.2013.07.018] [Citation(s) in RCA: 13] [Impact Index Per Article: 1.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/04/2013] [Revised: 06/10/2013] [Accepted: 07/27/2013] [Indexed: 12/11/2022]
Abstract
BACKGROUND The optimal immunochemical test to use for generalised mass screening is still under debate in France. AIM To compare the cost and effectiveness in biennial screening for colorectal cancer of fifteen strategies consisting of the three-stool sample un-rehydrated guaiac faecal occult blood test and three immunochemical tests: Magstream, FOB-Gold and OC-Sensor, at different positivity cut-off levels and stool-sample collection. METHODS A Markov model was used to compare these strategies in a general population of 100,000 individuals aged 50-74 over a 20-year period. RESULTS Immunochemical tests were efficient strategies compared with guaiac faecal occult blood test. When all 15 strategies were compared with each other, only five of them remained efficient: the one- and two-stool sample Magstream, the one- and two-stool sample FOB-Gold with the 176 ng/mL cut-off, and the two-stool sample OC-Sensor with the 150 ng/mL cut-off. Sensitivity analyses showed that, at an identical price, the one-stool sample OC-Sensor was the most efficient strategy, and outperformed FOB-Gold. CONCLUSION One-stool immunochemical testing can be considered a promising alternative to the guaiac faecal occult blood test for colorectal cancer mass screening in the general population. Competition between manufacturers should now be introduced to reduce purchase price differences.
Collapse
Affiliation(s)
| | | | - Vanessa Cottet
- INSERM U 866, Burgundy University, Dijon Cedex, France; Burgundy Registry of Digestive Cancer, INSERM U 866, Dijon, France
| | | | | | - Vincent Dancourt
- INSERM U 866, Burgundy University, Dijon Cedex, France; Burgundy Registry of Digestive Cancer, INSERM U 866, Dijon, France
| | - Jean Faivre
- INSERM U 866, Burgundy University, Dijon Cedex, France; Burgundy Registry of Digestive Cancer, INSERM U 866, Dijon, France
| |
Collapse
|
|
45
|
Liao CS, Lin YM, Chang HC, Chen YH, Chong LW, Chen CH, Lin YS, Yang KC, Shih CH. Application of quantitative estimates of fecal hemoglobin concentration for risk prediction of colorectal neoplasia. World J Gastroenterol 2013; 19:8366-8372. [PMID: 24363529 PMCID: PMC3857461 DOI: 10.3748/wjg.v19.i45.8366] [Citation(s) in RCA: 17] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/30/2013] [Revised: 08/15/2013] [Accepted: 08/29/2013] [Indexed: 02/06/2023] Open
Abstract
AIM: To determine the role of the fecal immunochemical test (FIT), used to evaluate fecal hemoglobin concentration, in the prediction of histological grade and risk of colorectal tumors.
METHODS: We enrolled 17881 individuals who attended the two-step colorectal cancer screening program in a single hospital between January 2010 and October 2011. Colonoscopy was recommended to the participants with an FIT of ≥ 12 ngHb/mL buffer. We classified colorectal lesions as cancer (C), advanced adenoma (AA), adenoma (A), and others (O) by their colonoscopic and histological findings. Multiple linear regression analysis adjusted for age and gender was used to determine the association between the FIT results and colorectal tumor grade. The risk of adenomatous neoplasia was estimated by calculating the positive predictive values for different FIT concentrations.
RESULTS: The positive rate of the FIT was 10.9% (1948/17881). The attendance rate for colonoscopy was 63.1% (1229/1948). The number of false positive results was 23. Of these 1229 cases, the numbers of O, A, AA, and C were 759, 221, 201, and 48, respectively. Regression analysis revealed a positive association between histological grade and FIT concentration (β = 0.088, P < 0.01). A significant log-linear relationship was found between the concentration and positive predictive value of the FIT for predicting colorectal tumors (R2 > 0.95, P < 0.001).
CONCLUSION: Higher FIT concentrations are associated with more advanced histological grades. Risk prediction for colorectal neoplasia based on individual FIT concentrations is significant and may help to improve the performance of screening programs.
Collapse
|
|
46
|
Well adjusted qualitative immunochemical faecal occult blood tests could be a promising alternative for inexpensive, high-quality colorectal cancer screening. Eur J Cancer Prev 2013; 22:305-10. [PMID: 23702679 DOI: 10.1097/cej.0b013e32835b6991] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/14/2022]
Abstract
Immunochemical faecal occult blood tests (iFOBTs) have been shown to have higher sensitivity to detect colorectal cancer (CRC) and its precursors than traditional guaiac-based faecal occult blood tests, but are more costly and require specific laboratory equipment. A number of qualitative iFOBTs have been developed, but their performance varied widely because of the large variation in positivity thresholds used for test positivity. We aimed to evaluate the performance of qualitative iFOBTs with well adjusted positivity thresholds in the screening setting. In a study of 229 participants who underwent screening colonoscopy in Germany (45 patients with CRC, 65 with advanced adenoma and 119 free of colorectal neoplasms), we evaluated the performance of two qualitative iFOBTs at five different positivity thresholds and compared it with the performance of a quantitative iFOBT. Receiver operating characteristic curves were constructed. The areas under the curve, and the sensitivity and specificity of the tests, were calculated. For both qualitative tests, sensitivities were around 30% for advanced adenoma and 80% for CRC at very high levels of specificity (98-99%). Comparison of results with the receiver operating characteristic curves for the quantitative test indicated that the qualitative tests yielded similarly high levels of sensitivity at comparable levels of specificity. In conclusion, with appropriate adjustment of positivity thresholds ensuring the levels of specificity required in population-based screening, qualitative, office-based iFOBTs can be an economic, qualitatively comparable alternative to quantitative iFOBTs.
Collapse
|
|
47
|
Abstract
Colorectal cancer (CRC) is a common, but preventable, disease and is the second most common cause of cancer-related deaths in the U.S. CRC screening has proven effective at reducing both the incidence and mortality of this disease, using any of a number of screening tests available. The test options range from the least invasive and least expensive to more invasive and costly options. Fecal occult blood testing is the oldest, least expensive, and least invasive of these options and has evolved from the poorly sensitive standard guaiac test to the newer and diagnostically superior fecal immunochemical test (FIT) for hemoglobin. This article explores the evolutionary history of fecal occult blood testing, examines test performance characteristics among different FOBTs, and evaluates the role of the FIT in programmatic CRC screening.
Collapse
Affiliation(s)
- Lukejohn W Day
- Division of Gastroenterology, Department of Medicine, San Francisco General Hospital and Trauma Center, 1001 Potrero Avenue, 3D-5, San Francisco, CA, 94110, USA,
| | | | | |
Collapse
|
|
48
|
Huang Y, Ge W, London V, Li Q, Cai S, Zhang S, Zheng S. Diagnostic inconsistency of faecal immunochemical tests for haemoglobin in population screening of colorectal cancer. Clin Chem Lab Med 2013; 51:2173-80. [PMID: 24145058 DOI: 10.1515/cclm-2013-0232] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/06/2013] [Accepted: 05/14/2013] [Indexed: 12/24/2022]
Abstract
BACKGROUND There is currently very little data available on the consistency of quantitative and qualitative faecal immunochemical test (FIT) for colorectal cancer screening. METHODS A representative random population (n=1889, 40-74 year olds) in Jiashan, China was invited for FIT screening in 2012. Faecal samples were collected by a single specimen collection device and simultaneously tested by a quantitative FIT (OC-SENSOR, OC) and two qualitative FITs (FIT A and FIT B with intrinsic positive haemoglobin cut-off concentrations of 20 μg Hb/g faeces and 40 μg Hb/g faeces, respectively). The observational criteria for a positive result of the qualitative FIT were set according to the density of the colour appearing in the test strip. The results produced by the quantitative and qualitative FIT for each sample were compared. κ coefficient was used to measure consistency. RESULTS A total of 1368 (72.4%) individuals returned faecal samples. Both FIT A and FIT B precisely identified all faecal samples with haemoglobin concentration above 100 μg Hb/g faeces, but the overall consistency was poor for OC & FIT A (κ=0.32, 95% CI 0.20-0.44) and was moderate for OC & FIT B (κ=0.74, 95% CI 0.64-0.85). A more favourable consistency (κ=0.64, 95% CI 0.57-0.72) was achieved when a different positive criterion was employed for FIT A. CONCLUSIONS The diagnostic inconsistency between quantitative and qualitative FITs mainly exists in the faecal samples with low haemoglobin concentrations. Refining the criterion for a positive result may be a feasible way to improve the accuracy of qualitative FIT.
Collapse
|
|
49
|
Faivre J. Ask the Experts: The current status of screening for colorectal cancer. COLORECTAL CANCER 2013. [DOI: 10.2217/crc.13.37] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/21/2022]
Abstract
Jean Faivre is professor of medicine in the Department of Gastroenterology at the University of Burgundy (Dijon, France). His research activities on epidemiology and clinical research on digestive cancers have been conducted in the Dijon INSERM Research Centre (U866). He is a member of the board of the European Cancer Prevention Organisation and of EUROCARE. He is currently president of the Board of the Latin Association of Cancer Registries. He was the French representative in the Advisory Committee of Cancer Experts of the EU, past president of the French Society of Gastroenterology, the French Federation of Digestive Oncology and the Oncology Federation of University Hospitals. He is a member of the French and of the International Network of Cancer Registries, as well as a member of the French Technical Group on cancer screening. Over the past 25 years he has had a particular interest in colorectal cancer screening.
Collapse
Affiliation(s)
- Jean Faivre
- Digestive Cancer Registry, INSERM U866; CHU; Medical Faculty, BP 87900, 21079 Dijon Cedex, France
| |
Collapse
|
|
50
|
Brenner H, Tao S. Superior diagnostic performance of faecal immunochemical tests for haemoglobin in a head-to-head comparison with guaiac based faecal occult blood test among 2235 participants of screening colonoscopy. Eur J Cancer 2013; 49:3049-54. [PMID: 23706981 DOI: 10.1016/j.ejca.2013.04.023] [Citation(s) in RCA: 190] [Impact Index Per Article: 15.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/15/2013] [Revised: 04/22/2013] [Accepted: 04/26/2013] [Indexed: 02/06/2023]
Abstract
There is increasing evidence that faecal immunochemical tests (FITs) for haemoglobin offer a number of advantages over traditional guaiac based faecal occult blood tests (gFOBTs). However, evidence on diagnostic performance from direct comparisons with colonoscopy findings in all participants in the average risk population is still sparse. We aimed for a head-to-head comparison of three quantitative FITs with a gFOBT among participants of the German screening colonoscopy programme. Pre-colonoscopy stool samples and colonoscopy reports were obtained from 2235 participants of screening colonoscopy in 2005-2009. To enhance comparability of diagnostic performance of the various tests, we assessed sensitivity, specificity, predictive values and likelihood ratios of FITs after adjusting the FIT cut-off haemoglobin (Hb) concentrations in such a way that FIT positivity rates equalled the positivity rate of the gFOBT. Colorectal cancer, advanced adenomas and other adenomas were found in 15 (0.7%), 207 (9.3%) and 398 (17.8%) participants. The gFOBT was positive in 111 (5.0%) participants, with sensitivities (specificities) for detecting colorectal cancer, any advanced neoplasm or any neoplasm of 33.3% (95.2%), 8.6% (95.4%) and 5.5% (95.2%). At the same positivity rate, all three FITs outperformed the gFOBT in all indicators. In particular, all sensitivities of FITs were approximately two to three times higher at increased levels of specificity. All differences were statistically significant, except for some of the performance indicators for colorectal cancer. In conclusion, FITs can detect much larger proportions of colorectal neoplasms even if their cut-offs are set to levels that ensure equally low positivity rates as gFOBT.
Collapse
Affiliation(s)
- Hermann Brenner
- Division of Clinical Epidemiology and Aging Research, German Cancer Research Center, Im Neuenheimer Feld, 69120 Heidelberg, Germany.
| | | |
Collapse
|