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

Zhongshan City People's Hospital

Status: Enrolling

Conditions: Hepatocellular Cancer (HCC)

Treatments: Biological: Measurement Indicators Required for Risk Scoring in HCC Screening Strategies; Biological: Follow-Up Monitoring Parameters; Diagnostic Test: Quantitative HBeAg Testing

Study type: Observational

Funder types: Other

Identifiers

NCT07010198

HCC-2025-01

Details and patient eligibility

About

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.

Enrollment: 4,500 estimated patients

Sex: All

Ages: 35+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

4,500 participants in 1 patient group

HCC Screening Dynamic Cohort

Description:

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

Treatment:

Diagnostic Test: Quantitative HBeAg Testing

Biological: Follow-Up Monitoring Parameters

Biological: Measurement Indicators Required for Risk Scoring in HCC Screening Strategies