An observational study in Hepatocellular Cancer (HCC), sponsored by Zhongshan People's Hospital, Guangdong, China. Recruiting at 1 site in China. Open to participants aged 35 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-08.
Sponsored by Zhongshan People's Hospital, Guangdong, China · Observational
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.
Local household-registered residents aged ≥35 years, HBsAg-positive, with no prior diagnosis of HCC, residing in Zhongshan City.
Exclusion Criteria:
Local household-registered residents aged 35-64 years who are HBsAg-positive and have not been diagnosed with HCC prior to enrollment, residing in the study site communities of Zhongshan City
Diagnostic Test: Quantitative HBeAg Testing · Biological: Measurement Indicators Required for Risk Scoring in HCC Screening Strategies · Biological: Follow-Up Monitoring Parameters
Quantitative HBeAg Testing in Population-Based Primary Screening
REACH-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.
AFP, 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.
Time frame: 3 years
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.
Time frame: 3 years
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.
Time frame: 3 years
Screening positivity and referral rate
Proportion of participants identified as medium/high-risk and referred for further diagnostic imaging (e.g.,pathology/CT/MRI).
Time frame: 3 years
Stage distribution of HCC cases identified by different screening strategies
Time frame: 3 years
Early detection rate of HCC cases identified by different screening strategies
Time frame: 3 years
Number Needed to Screen (NNS)
Number of individuals needed to be screened to prevent one case of HCC.
Time frame: 3 years
Incremental Cost-Effectiveness Ratio (ICER)
The additional cost required to gain one extra QALY or to prevent one HCC case using a given model, compared with baseline strategy.
Time frame: 3 years
Time-dependent AUC or C-index
Model discrimination assessed at different time points using time-dependent ROC curves and concordance index (C-index).
Time frame: 3 years
Model performance in subgroups
Subgroup analyses to compare predictive performance of each model in different populations (e.g., by sex, age, ALT level, HBV DNA level).
Time frame: 3 years
Overall survival (OS)
Indicates whether the participant was alive at the end of follow-up and their survival duration.
Time frame: 3 years
Screening adherence
The proportion of participants who completed biannual AFP and ultrasound screenings as scheduled during follow-up.
Time frame: 3 years
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Zhongshan People's Hospital, Guangdong, China