Comparing different ways to screen for liver cancer in people with hepatitis B in Zhongshan City
Head-to-Head Comparison of Hepatocellular Cancer (HCC) Screening Strategies: A Prospective Population-Based Cohort Study in Zhongshan City
This project tests different screening methods to see which finds liver cancer earliest in adults 35 and older who are positive for hepatitis B in Zhongshan City.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 4500 (estimated) |
| Ages | 35 Years and up |
| Sex | All |
| Sponsor | Zhongshan People's Hospital, Guangdong, China Academic / other |
| Locations | 1 site (Zhongshan, Guangdong) |
| Trial ID | NCT07010198 on ClinicalTrials.gov |
What this trial studies
This is a prospective, single-center, population-based head-to-head comparison of multiple hepatocellular carcinoma (HCC) screening strategies in Zhongshan City. The study will recruit roughly 4,500 HBsAg-positive adults through an initial HBV screening phase and then follow them with uniform HCC surveillance using AFP plus liver ultrasound every six months. Different risk stratification models (conventional AFP+ultrasound general strategy, REACH-B, AGED, aMAP, and aMAP 3.0) will be applied concurrently to each participant to compare detection rates and risk classification. Clinical and laboratory measures such as quantitative HBeAg and other indicators required for the risk scores will be collected and monitored during follow-up.
Who should consider this trial
Good fit: Adults aged 35 or older who live in Zhongshan, test positive for HBsAg, can provide informed consent, and do not have a prior history of liver cancer or liver transplantation.
Not a fit: People who are HBsAg-negative, younger than 35, pregnant, have prior liver cancer or transplant, have severe comorbidities, or cannot consent are unlikely to receive benefit from participating.
Why it matters
Potential benefit: If successful, this could identify the most effective screening approach to detect liver cancer earlier in people with chronic hepatitis B, improving chances for curative treatment.
How similar studies have performed: Retrospective validation in Xiaolan Town showed promising results for the five scoring methods, but a prospective head-to-head comparison in this population is novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Zhongshan, Guangdong
- Zhongshan People's Hospital — Zhongshan, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Mingfang Ji, MD
- Email: jmftbh@sina.com
- Phone: 86-0760-89880417
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.