Risk Assessment for HBV-Related Liver Cancer

NCT07160946 | Recruiting DMC

• 1 other identifier: Spark Liver Health
• Study Type: observational
• Target: 6,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HBV-related Liver Cirrhosis

Outcome Measures

Primary Outcomes (1)

• Number and specific time of participants progressing to liver cancer

  Number and specific time of participants progressing to liver cancer

  5 years

Secondary Outcomes (1)

• Survival time

  5 years

Other Outcomes (1)

• Incidence of adverse events for the participants

  5 years

Study Arms (2)

Routine follow-up group

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

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.

Other: AI folow-up system

Interventions

AI folow-up system OTHER

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

AI system follow-up group

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The diagnostic rate of stage I liver cancer in China (AJCC-7 TNM staging system) is 17.5%. It is planned to increase the diagnostic rate of stage I liver cancer by 50% through this project, reaching 26.3%, power=0.9, a=0.05. PASS software calculated that a total of 958 liver cancer patients need to be enrolled in both groups. It is known that the annual incidence of liver cancer in patients with hepatitis B cirrhosis is 3% -6%. If calculated by 4%, it is estimated that the patients will be enrolled in one year, followed up for five years, and the lost rate is 10%, 5470 patients will need to be enrolled. Ultimately, this study plans to enroll 6000 patients.

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510630, China

RECRUITING

Related Publications (2)

• 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 BACKGROUND

• 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 BACKGROUND

Related Links

• Related Info

Central Study Contacts

Bingliang Prof. Lin

CONTACT

+86-20-85252081; linbingl@mail.sysu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: August 2, 2025
• First Posted: September 8, 2025
• Study Start: May 10, 2025
• Primary Completion (Estimated): December 30, 2032
• Study Completion (Estimated): December 30, 2032
• Last Updated: September 8, 2025

Record last verified: 2025-07

Locations

CN (1)