RecruitingNCT07010198

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


Sponsor

Zhongshan People's Hospital, Guangdong, China

Enrollment

4,500 participants

Start Date

Mar 1, 2025

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 35 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing different screening methods for early detection of liver cancer in people who have chronic hepatitis B — a viral infection that significantly raises the risk of developing liver cancer. **You may be eligible if...** - You live in Zhongshan City, Guangdong Province, China - You are 35 years or older - You have tested positive for hepatitis B surface antigen (HBsAg), meaning you carry the hepatitis B virus **You may NOT be eligible if...** - You have already been diagnosed with liver cancer or have had a liver transplant - You are pregnant - You have severe illness such as advanced heart or lung disease or another advanced cancer - You are unable to provide informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTQuantitative HBeAg Testing

Quantitative HBeAg Testing in Population-Based Primary Screening

BIOLOGICALMeasurement Indicators Required for Risk Scoring in HCC Screening Strategies

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.

BIOLOGICALFollow-Up Monitoring Parameters

AFP, Liver Ultrasound


Locations(1)

Zhongshan People's Hospital

Zhongshan, Guangdong, China

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NCT07010198


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