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Copyright ©The Author(s) 2015.
World J Gastroenterol. Oct 7, 2015; 21(37): 10573-10583
Published online Oct 7, 2015. doi: 10.3748/wjg.v21.i37.10573
Table 1 Phases of biomarker validation for early cancer detection
Phase of biomarker validationType of studyAimBiomarker
Phase IPreclinical exploratoryIdentify promising markers
Phase IICase-controlClinical assay to detect HCCAFP-L3, DCP, GPC3, OPN, GP73, SCCA, annexin A2
suPAR, MDK, AXL, TRX, nucleic acids, miRNA
Phase IIIRetrospective longitudinalCharacterize ability of biomarker to detect HCC before it becomes clinical
Phase IVProspective screeningIdentify extent and characteristics of sensitivity and specificity
Phase VRandomized controlDetermine if biomarker screening can reduce mortality in target populationAFP