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RECRUITING
NCT07010198

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

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

35 Years - Any

Study Type

OBSERVATIONAL

Enrollment

4500

Start Date

2025-03-01

Completion Date

2028-12-31

Last Updated

2025-06-08

Healthy Volunteers

Yes

Interventions

DIAGNOSTIC_TEST

Quantitative HBeAg Testing

Quantitative HBeAg Testing in Population-Based Primary Screening

BIOLOGICAL

Measurement 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.

BIOLOGICAL

Follow-Up Monitoring Parameters

AFP, Liver Ultrasound

Locations (1)

Zhongshan People's Hospital

Zhongshan, Guangdong, China