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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

— Observational Hepatocellular Cancer (HCC)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Quantitative HBeAg Testing, Measurement Indicators Required for Risk Scoring in HCC Screening Strategies, Follow-Up Monitoring Parameters.
Who it may be relevant to
Registry conditions: Hepatocellular Cancer (HCC). Basic parameters: from 35 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

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

Primary outcome measures

  • Incidence of HCC [Time frame: 3 years]
  • Predictive performance (Sensitivity, Specificity, Positive Predictive value, AUC, etc.) [Time frame: 3 years]
  • Risk stratification accuracy [Time frame: 3 years]
Secondary outcome measures (9)
  • Screening positivity and referral rate [Time frame: 3 years]
  • Stage distribution of HCC cases identified by different screening strategies [Time frame: 3 years]
  • Early detection rate of HCC cases identified by different screening strategies [Time frame: 3 years]
  • Number Needed to Screen (NNS) [Time frame: 3 years]
  • Incremental Cost-Effectiveness Ratio (ICER) [Time frame: 3 years]
  • Time-dependent AUC or C-index [Time frame: 3 years]
  • Model performance in subgroups [Time frame: 3 years]
  • Overall survival (OS) [Time frame: 3 years]
  • Screening adherence [Time frame: 3 years]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Zhongshan People's Hospital — Zhongshan

Identifiers

NCT: NCT07010198 · HCC-2025-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗