HCC Risk Prediction Model Based on Multimodal Data in Chronic Hepatitis B
Development and Application of an HCC Risk Prediction Model Based on Multimodal Data in Chronic Hepatitis B
2 other identifiers
observational
2,000
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2026
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 19, 2026
CompletedStudy Start
First participant enrolled
August 20, 2026
CompletedFirst Posted
Study publicly available on registry
August 21, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
August 28, 2026
August 1, 2026
1 year
August 19, 2026
August 26, 2026
Conditions
Keywords
Outcome Measures
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.
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
Aug, 2026 - Aug, 2028
Study Arms (2)
HCC group
Participants who developed HCC within 5 years after enrollment
Non-HCC group
Participants who did not develop HCC within 5 years after enrollment
Interventions
No intervention (observational study)
Eligibility Criteria
Patients with HBV-related fibrosis/cirrhosis on antiviral therapy from a multicenter retrospective cohort, with available longitudinal clinical data, serum glycomics, and liver histopathology.
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Beijing Friendship Hospitallead
- The Second Hospital & Clinical Medical School, Lanzhou Universitycollaborator
- Beijing Ditan Hospitalcollaborator
- Yuncheng Central Hospitalcollaborator
- Guangzhou Eighth People's Hospital, Guangzhou Medical University.collaborator
Study Sites (1)
Beijing Friendship Hospital, Capital Medical University
Beijing, Xicheng, 100050, China
Related Publications (5)
Lee HW, Kim H, Park T, Park SY, Chon YE, Seo YS, Lee JS, Park JY, Kim DY, Ahn SH, Kim BK, Kim SU. A machine learning model for predicting hepatocellular carcinoma risk in patients with chronic hepatitis B. Liver Int. 2023 Aug;43(8):1813-1821. doi: 10.1111/liv.15597.
PMID: 37452503RESULTTruong TN, Pham TND, Hoang LB, Nguyen VT, Dao HV, Dao DVB, Alessy S, Pham HB, Pham TTT, Nguyen LDD, Nguyen K, Abaalkhail F, Manal M, Mawardi M, AlZahrani M, Alswat K, Alghamdi H, Sanai FM, Siddiqui MA, Nguyen NH, Vaidya D, Phan HT, Johnson PJ, Alqahtani SA, Dao DY. Surveillance and treatment of primary hepatocellular carcinoma (aka. STOP HCC): protocol for a prospective cohort study of high-risk patients for HCC using GALAD-score. BMC Cancer. 2023 Sep 18;23(1):875. doi: 10.1186/s12885-023-11167-9.
PMID: 37723439RESULTChun HS, Papatheodoridis GV, Lee M, Lee HA, Kim YH, Kim SH, Oh YS, Park SJ, Kim J, Lee HA, Kim HY, Kim TH, Yoon EL, Jun DW, Ahn SH, Sypsa V, Yurdaydin C, Lampertico P, Calleja JL, Janssen H, Dalekos GN, Goulis J, Berg T, Buti M, Kim SU, Kim YJ. PAGE-B incorporating moderate HBV DNA levels predicts risk of HCC among patients entering into HBeAg-positive chronic hepatitis B. J Hepatol. 2024 Jan;80(1):20-30. doi: 10.1016/j.jhep.2023.09.011. Epub 2023 Sep 19.
PMID: 37734683RESULTShi JY, Wang X, Ding GY, Dong Z, Han J, Guan Z, Ma LJ, Zheng Y, Zhang L, Yu GZ, Wang XY, Ding ZB, Ke AW, Yang H, Wang L, Ai L, Cao Y, Zhou J, Fan J, Liu X, Gao Q. Exploring prognostic indicators in the pathological images of hepatocellular carcinoma based on deep learning. Gut. 2021 May;70(5):951-961. doi: 10.1136/gutjnl-2020-320930. Epub 2020 Sep 30.
PMID: 32998878RESULTQiu S, Cai J, Yang Z, He X, Xing Z, Zu J, Xie E, Henry L, Chong CR, John EM, Cheung R, Ji F, Nguyen MH. Trends in Hepatocellular Carcinoma Mortality Rates in the US and Projections Through 2040. JAMA Netw Open. 2024 Nov 4;7(11):e2445525. doi: 10.1001/jamanetworkopen.2024.45525.
PMID: 39556395RESULT
Biospecimen
Using previously used serum samples for the detection of liver cancer markers
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 19, 2026
First Posted
August 21, 2026
Study Start
August 20, 2026
Primary Completion (Estimated)
August 31, 2027
Study Completion (Estimated)
December 31, 2028
Last Updated
August 28, 2026
Record last verified: 2026-08