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Recruiting NCT07160946

Risk Assessment for HBV-Related Liver Cancer

Observational HBV-related Liver Cirrhosis

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: AI folow-up system.
Who it may be relevant to
Registry conditions: HBV-related Liver Cirrhosis. Basic parameters: 30 years — 75 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 →
Official title

Research on Risk Assessment and Intervention of HBV-Related Liver Cancer Based on Multimodal Data Fusion

Overview

Liver cancer is a severe disease worldwide. The incidence and mortality rates of liver cancer in China is the highest in the world. This project aims to perform a prospective, multi-center, large sample cohort study for HBV related high-risk individuals. Based on multimodal data fusion and AI technique, stratified management and follow-up system are conducted for HBV-related high-risk populations of liver cancer, in order to improve the early diagnosis rate of liver cancer.

Interventions

  • Other AI folow-up system
    In AI follow-up group, patients will be followed up by an AI system.

Primary outcome measures

  • Number and specific time of participants progressing to liver cancer [Time frame: 5 years]
Secondary outcome measures (1)
  • Survival time [Time frame: 5 years]

Eligibility 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.

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

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Third Affiliated Hospital of Sun Yat-sen University — Guangzhou

Publications

  • Shan T, Ran X, Li H, Feng G, Zhang S, Zhang X, Zhang L, Lu L, An L, Fu R, Sun K, Wang S, Chen R, Li L, Chen W, Wei W, Zeng H, He J. Disparities in stage at diagnosis for liver cancer in China. J Natl Cancer Cent. 2023 Jan 3;3(1):7-13. doi: 10.1016/j.jncc.2022.12.002. eCollection 2023 Mar. PMID 39036312
  • Singh SP, Madke T, Chand P. Global Epidemiology of Hepatocellular Carcinoma. J Clin Exp Hepatol. 2025 Mar-Apr;15(2):102446. doi: 10.1016/j.jceh.2024.102446. Epub 2024 Oct 28. PMID 39659901

Identifiers

NCT: NCT07160946 · Spark Liver Health

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗