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NCT Number: NCT07780357

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

We 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Friendship Hospital, Capital Medical University

Beijing, Xicheng, 100050, China

Location contact

Jialing Zhou

CONTACT

[email protected]

860+010-63138665

Jianping Li, Doctor of Medicine

PRINCIPAL_INVESTIGATOR

Junwei Li

CONTACT

[email protected]

Liang Wang, Doctor of Medicine

PRINCIPAL_INVESTIGATOR

Liuyi Chang, Doctor of Medicine

PRINCIPAL_INVESTIGATOR

About this study

We 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Availability of baseline data and at least two longitudinal follow-up visits.
  • Clinical outcomes during the follow-up period are traceable.

Exclusion criteria

  • 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).

Treatment and study plan

No intervention (observational study)

Other

No intervention (observational study)

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

    Time frame: Aug, 2026 - Aug, 2027

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

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

    Time frame: Aug, 2026 - Aug, 2028

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

Study contacts

Contact information is provided by the study sponsor or research team.

Jialing Zhou

CONTACT

[email protected]

860+010-63138665

Sponsors and collaborators

Lead sponsor

Beijing Friendship Hospital

Other

Collaborators

  • Guangzhou Eight People's Hospital, Guangzhou Medical University
  • The NO.2 People's Hospital of Lanzhou
  • Yuncheng People's Hospital

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Aug 21, 2026
Registry last updated
Aug 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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