Clinical trial · Observational
Head-to-Head Comparison of Hepatocellular Cancer (HCC) Screening Strategies: A Prospective Population-Based Cohort Study in Zhongshan City
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Cancer (HCC) | Hepatocellular Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Follow-Up Monitoring Parameters | Biological | — | UNRESOLVED |
| Measurement Indicators Required for Risk Scoring in HCC Screening Strategies | Biological | — | UNRESOLVED |
| Quantitative HBeAg Testing | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- HCC Screening Dynamic Cohort
- description
- Local household-registered residents aged 35-64 years who are HBsAg-positive and have not been diagnosed with HCC prior to enrollment, residing in the study site communities of Zhongshan City
- interventionNames
- Diagnostic Test: Quantitative HBeAg Testing
- Biological: Measurement Indicators Required for Risk Scoring in HCC Screening Strategies
- Biological: Follow-Up Monitoring Parameters
Primary outcomes (3)
- measure
- Incidence of HCC
- timeFrame
- 3 years
- description
- The number of newly diagnosed HCC cases divided by total person-years at risk during follow-up for each screening strategy.
- measure
- Predictive performance (Sensitivity, Specificity, Positive Predictive value, AUC, etc.)
- timeFrame
- 3 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 35 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available