NCT07010198

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 4,500 (estimated)
• Sponsor: Zhongshan People's Hospital, Guangdong, China · Academic / Other
• Sex: All
• Age: 35 Years
• Healthy volunteers: Accepted

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.

Conditions

• Hepatocellular Cancer (HCC)

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-03-01
• Primary completion: 2025-12-31
• Completion: 2028-12-31
• First posted: 2025-06-08
• Last updated: 2025-06-08

Locations

1 site across 1 country: China