Risk prediction for HBV-related liver cancer
Official title: Research on Risk Assessment and Intervention of HBV-Related Liver Cancer Based on Multimodal Data Fusion
Run by Sun Yat-sen University · NCT07160946 · Data updated 2026-11-12
This project tests an AI-based follow-up system to try to improve early detection of liver cancer in people with chronic hepatitis B and related risk factors.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 30 Years to 75 Years |
| Sex | All |
| Enrollment | 6000 (estimated) |
| Sponsor | Sun Yat-sen University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Status | Recruiting |
| Started | May 10, 2025 |
| Main results expected | December 30, 2032 |
| Study ends | December 30, 2032 |
| Registry record updated | September 8, 2025 |
| Trial ID | NCT07160946 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults positive for hepatitis B surface antigen who also have liver cirrhosis or at least one risk factor such as type 2 diabetes, family history of liver cirrhosis/liver cancer, long-term heavy alcohol use, Metavir fibrosis score F3 or above, or Fibroscan (LSM) ≥ 8.0 kPa.
✕Probably not a fit
People already diagnosed with malignant tumors, those post-liver transplantation, individuals with HIV infection, patients with expected survival under one year, or those with marked organ dysfunction or severe psychiatric illness are excluded and unlikely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, multicenter cohort enrolling people positive for hepatitis B surface antigen who meet cirrhosis or other risk criteria and following them with an AI-driven, multimodal data fusion follow-up system. The program combines clinical information, imaging, elastography, pathology where available, and other markers to stratify patients by liver cancer risk and guide surveillance intervals. Enrolled participants receive structured, risk-based management and scheduled follow-up aimed at earlier detection of hepatocellular carcinoma. The primary intent is to increase the early diagnosis rate of liver cancer through targeted surveillance in a large sample across participating centers.
Why it matters
Potential benefit: If successful, the AI-driven follow-up could identify liver cancer earlier in high-risk hepatitis B patients, allowing timelier treatment and improved outcomes.
How similar studies have gone: Similar approaches using risk models and AI for hepatocellular carcinoma surveillance have shown promising early results but are not yet widely validated in large prospective multicenter cohorts.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: must meet (a) and any one of (b) to (g). * (a).Positive for Hepatitis B surface antigen; (b).Ultrasound/CT/MR indicates liver cirrhosis; (c). Type II diabetes; (d). Has family history of liver cirrhosis/ liver cancer; (e). Long term alcohol consumption history (\>5 years), equivalent to alcohol consumption of ≥ 40g/d for males and ≥ 20g/d for females; (f). Liver histology Metavir fibrosis score F3 or above; (g). Fibroscan value (LSM) ≥ 8.0kPa. Exclusion Criteria: * (a).Diagnosed with malignant tumors; (b). Post liver transplantation; (c). Infected with HIV; (d). Expected survival time\<1 year; (e). With marked organ dysfunctions(heart, brain, kidney, lung, endocrine system, blood, etc.) or psychiatric patients.
Where it's running
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Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China Recruiting
Study contacts
- Study coordinator: Bingliang Prof. Lin
- Email: linbingl@mail.sysu.edu.cn
- Phone: +86-20-85252081
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.