Head-to-Head Comparison of Hepatocellular Cancer (HCC) Screening Strategies: A Prospective Population-Based Cohort Study in Zhongshan City
NCT07010198
Summary
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.
Eligibility
Inclusion Criteria: * 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). Exclusion Criteria: * 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.
Conditions4
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NCT07010198