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

Recruiting now

Conditions studied: Hepatocellular Cancer (HCC)

In brief

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.

Key facts

Study ID

NCT07010198

Run by

Zhongshan People's Hospital, Guangdong, China

People needed

4500

Starts

2025-03-01

Expected to finish

2028-12-31

Last updated by the study team

2025-06-08

Who can join

Age: 35 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Zhongshan People's Hospital — Zhongshan, Guangdong, China (enrolling)

Full record on ClinicalTrials.gov

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