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

August 26, 2026 updated by: Beijing Friendship Hospital

Development and Application of an HCC Risk Prediction Model Based on Multimodal Data in Chronic Hepatitis B

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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. Approximately 2,000 participants (200 HCC and 1,800 non-HCC) will be included. Model performance will be assessed by AUROC, sensitivity, and specificity through training and validation procedures, with the goal of developing a scalable HCC risk prediction method and software tool for clinical application.

Study Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Xicheng
      • Beijing, Xicheng, China, 100050
        • Beijing Friendship Hospital, Capital Medical University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jianping Li, Doctor of Medicine
        • Principal Investigator:
          • Liang Wang, Doctor of Medicine
        • Principal Investigator:
          • Liuyi Chang, Doctor of Medicine
        • Principal Investigator:
          • Wenshan zhao, Doctor of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study 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.

Description

Inclusion Criteria:

  1. Aged ≥18 years, both sexes eligible.
  2. Diagnosed with hepatitis B-related liver fibrosis or cirrhosis based on clinical assessment or liver histopathology.
  3. Undergoing antiviral treatment.
  4. Follow-up duration between 0.5- 5 years.
  5. Availability of baseline data and at least two longitudinal follow-up visits.
  6. Clinical outcomes during the follow-up period are traceable.

Exclusion Criteria:

  1. Diagnosis of Hepatocellular carcinoma (HCC) or liver transplantation at baseline or within 6 months after baseline/enrollment.
  2. Coexisting other chronic liver diseases, such as genetic/metabolic liver diseases, drug-induced liver injury, or severe steatotic liver disease.
  3. Coexisting other malignancies (except those considered cured).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
HCC group
Participants who developed HCC within 5 years after enrollment
Other: No intervention (observational study)
No intervention (observational study)
Non-HCC group
Participants who did not develop HCC within 5 years after enrollment
Other: No intervention (observational study)
No intervention (observational study)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: Aug, 2026 - Aug, 2027
Evaluation metrics include AUROC, sensitivity, specificity, positive predictive value, negative predictive value, and calibration.
Aug, 2026 - Aug, 2027

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: Aug, 2026 - Aug, 2028
Evaluation metrics include AUROC, sensitivity, specificity, positive predictive value, negative predictive value, and calibration.
Aug, 2026 - Aug, 2028

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Friendship Hospital

Collaborators

Beijing Ditan Hospital
Yuncheng Central Hospital
The Second Hospital & Clinical Medical School, Lanzhou University
Guangzhou Eighth People's Hospital, Guangzhou Medical University.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 20, 2026

Primary Completion (Estimated)

August 31, 2027

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

August 19, 2026

First Submitted That Met QC Criteria

August 19, 2026

First Posted (Actual)

August 21, 2026

Study Record Updates

Last Update Posted (Actual)

August 28, 2026

Last Update Submitted That Met QC Criteria

August 26, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CFH-2026-1Q-1022
  • 2026-1Q-1022 (Other Grant/Funding Number: Capital's Funds for Health Improvement and Research)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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