Risk Assessment for HBV-Related Liver Cancer

Sun Yat-sen University

Status: Enrolling

Conditions: HBV-related Liver Cirrhosis

Treatments: Other: AI folow-up system

Study type: Observational

Funder types: Other

Identifiers

NCT07160946

Spark Liver Health

Details and patient eligibility

About

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.

Enrollment: 6,000 estimated patients

Sex: All

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and 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.

Trial design

6,000 participants in 2 patient groups

Routine follow-up group

Description:

Patients in this cohor will be followed up every 24 weeks (or every 8-12 weeks for extremely high-risk population) routinely. Alpha fetoprotein, PIVKA-II, liver imaging examination, liver function, et al will be performed for these patients at each follow-up point.

AI system follow-up group

Description:

Patients in this cohor will be followed up every 24 weeks (or every 8-12 weeks for extremely high-risk population). Alpha fetoprotein, PIVKA-II, liver imaging examination, liver function, et al will be performed for these patients at each follow up point. An AI system will be used to manage follow-up patients.

Treatment:

Other: AI folow-up system