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Recruiting

NCT Number: NCT07160946

Risk Assessment for HBV-Related Liver Cancer

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.

Recruiting

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Key information

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510630, China

Location status: Recruiting

Location contact

Bingliang Prof. Lin

CONTACT

[email protected]

+86-20-85252081

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AI folow-up system

Other

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

Primary outcomes

  1. Number and specific time of participants progressing to liver cancer

    Time frame: 5 years

    Number and specific time of participants progressing to liver cancer

Secondary outcomes

  1. Survival time

    Time frame: 5 years

    Participants' survival time after being diagnosed with liver cancer.

Other outcomes

  1. Incidence of adverse events for the participants

    Time frame: 5 years

    Incidence of ascite, hepatorenal system, hepatic encephalopathy, gastrointestinal bleeding, etc. for all the participants.

Study contacts

Contact information is provided by the study sponsor or research team.

Bingliang Prof. Lin

CONTACT

[email protected]

+86-20-85252081

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2032
Study completion
2032
First posted
Sep 8, 2025
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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