Risk Assessment for HBV-Related Liver Cancer

ConditionHBV-related Liver Cirrhosis

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age30-75

SponsorSun Yat-sen University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

(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.

Disqualifiers

(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 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

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

Treatment groups

6,000 Participants

are divided into 2 treatment groups

Group A: Routine follow-up group0 interventions

Group B: AI system follow-up group1 intervention

Trial outcomes

Primary outcomes

Number and specific time of participants progressing to liver cancer

Time frame

5 years

Secondary outcomes

Survival time

Participants' survival time after being diagnosed with liver cancer.

Time frame

5 years

Other outcomes

Incidence of adverse events for the participants

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

Time frame

5 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sun Yat-sen University

Lead sponsor

Source ClinicalTrials.gov

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