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

Inclusion Criteria4

  • 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 Criteria4

  • 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.

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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