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Head-to-Head Comparison of Hepatocellular Cancer (HCC) Screening Strategies: A Prospective Population-Based Cohort Study in Zhongshan City

Head-to-Head Comparison of Hepatocellular Cancer (HCC) Screening Strategies: A Prospective Population-Based Cohort Study in Zhongshan City

Recruiting
35 years and older
All
Phase N/A

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Overview

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.

Study details
    Hepatocellular Cancer (HCC)

NCT07010198

Zhongshan People's Hospital, Guangdong, China

15 October 2025

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