Based on the preliminary retrospective validation of the efficacy of five HCC screening strategies(including conventional AFP combined with ultrasound-based general screening strategy, REACH-B, AGED, aMAPand aMAP 3.0 risk score) in Xiaolan Town, a head-to-head comparison for HCC screening is conducted in Zhongshan City, Guangdong Province. The study is a prospective, single-center, head-to-head trial aiming to enroll 4,500 HBsAg-positive individuals. It adopts a two-phase design of "HBV screening first, followed by HCC surveillance":Phase I: Recruitment of age-eligible populations at study sites for HBsAg screening to establish a high-risk cohort positive for hepatitis B surface antigen.Phase II: Implementation of uniform HCC surveillance (AFP combined with liver ultrasound every six months) for HBsAg-positive individuals, with concurrent application of different risk stratification models to evaluate risk levels and screening efficacy for each participant during follow-up.Furthurmore, based on baseline biological information and follow-up data, the study also aims to explore the development of a more effective risk prediction model for HCC.
Voluntarily sign the informed consent form.
Household registration in Zhongshan City, Guangdong Province.
Aged 35 and above.
Positive screening result for Hepatitis B surface antigen (HBsAg).
Previous history of liver cancer or liver transplantation.
Pregnant women.
Severe comorbidities (e.g., end-stage cardiopulmonary diseases, advanced malignancies).
Individuals lacking legal capacity or unable to provide informed consent.
Local household-registered residents aged ≥35 years, HBsAg-positive, with no prior diagnosis of HCC, residing in Zhongshan City.
Cohort
Prospective
Quantitative HBeAg Testing
Diagnostic testQuantitative HBeAg Testing in Population-Based Primary Screening
Measurement Indicators Required for Risk Scoring in HCC Screening Strategies
Biological/VaccineREACH-B: Age, Sex, HBeAg status, ALT levels, and HBV DNA load; AGED: Age, Sex, HBeAg status, HBV DNA load; aMAP: Age, Sex, Albumin, Total Bilirubin, Platelet Count; aMAP 3.0: Age, Sex, Albumin, Total Bilirubin, Platelet Count, AFP and PIVKA-II.
Follow-Up Monitoring Parameters
Biological/VaccineAFP, Liver Ultrasound
Incidence of HCC
The number of newly diagnosed HCC cases divided by total person-years at risk during follow-up for each screening strategy.
Predictive performance (Sensitivity, Specificity, Positive Predictive value, AUC, etc.)
Sensitivity, specificity, positive predictive value(PPV) and area under the ROC curve (AUC) will be calculated to evaluate the discrimination of each model.
Risk stratification accuracy
Participants will be categorized into different risk strata (high, intermediate, low) by each model, and their observed HCC incidence will be compared to assess stratification accuracy.
Screening positivity and referral rate
Proportion of participants identified as medium/high-risk and referred for further diagnostic imaging (e.g.,pathology/CT/MRI).
Stage distribution of HCC cases identified by different screening strategies
Early detection rate of HCC cases identified by different screening strategies
Number Needed to Screen (NNS)
Number of individuals needed to be screened to prevent one case of HCC.
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