HCC Risk Prediction Model Based on Multimodal Data in Chronic Hepatitis B

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBeijing Friendship Hospital

About this trial

The investigators propose to construct and validate an early HCC risk prediction model in a multicenter retrospective cohort of hepatitis B-related fibrosis/cirrhosis patients, using multimodal data encompassing longitudinal clinical data, serum glycomics profiles, and liver biopsy histopathological images.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged ≥18 years, both sexes eligible.

Diagnosed with hepatitis B-related liver fibrosis or cirrhosis based on clinical assessment or liver histopathology.

Undergoing antiviral treatment.

Follow-up duration between 0.5- 5 years.

Disqualifiers

Diagnosis of Hepatocellular carcinoma (HCC) or liver transplantation at baseline or within 6 months after baseline/enrollment.

Coexisting other chronic liver diseases, such as genetic/metabolic liver diseases, drug-induced liver injury, or severe steatotic liver disease.

Coexisting other malignancies (except those considered cured).

Trial population

Patients with HBV-related fibrosis/cirrhosis on antiviral therapy from a multicenter retrospective cohort, with available longitudinal clinical data, serum glycomics, and liver histopathology.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • No intervention (observational study)

    Other intervention

    No intervention (observational study)

Treatment groups

2,000 Participants
are divided into 2 treatment groups
Group A: HCC group1 intervention
Group B: Non-HCC group1 intervention

Trial outcomes

Primary outcomes

1

To evaluate the predictive performance of an early-stage HCC risk prediction model integrating longitudinal clinical data and serum glycomics biomarkers in patients with hepatitis B-related fibrosis

Evaluation metrics include AUROC, sensitivity, specificity, positive predictive value, negative predictive value, and calibration.

Time frame
Aug, 2026 - Aug, 2027

Secondary outcomes

1

To evaluate the predictive performance of an early HCC risk prediction model integrating liver histopathological imaging with longitudinal clinical and serum glycomics data in patients with hepatitis B-related fibrosis

Evaluation metrics include AUROC, sensitivity, specificity, positive predictive value, negative predictive value, and calibration.

Time frame
Aug, 2026 - Aug, 2028

Other outcomes

Sponsors and contacts

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

Beijing Friendship Hospital

Lead sponsor

The Second Hospital & Clinical Medical School, Lanzhou University

Collaborator

Beijing Ditan Hospital

Collaborator

Yuncheng Central Hospital

Collaborator

Guangzhou Eighth People's Hospital, Guangzhou Medical University.

Collaborator

This trial is not recruiting at the moment. You can still explore other options: