Clinical trial · Observational

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

NCT07780357CI-TRIAL-00124420not yet recruitingClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Hepatocellular Carcinoma (HCC)	Hepatocellular Carcinoma	ONTOLOGY_EXACT	0.85

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
No intervention (observational study)	Other	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

label
HCC group
description
Participants who developed HCC within 5 years after enrollment
interventionNames
1. Other: No intervention (observational study)
label
Non-HCC group
description
Participants who did not develop HCC within 5 years after enrollment
interventionNames
1. Other: No intervention (observational study)

Primary outcomes (1)

measure
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
timeFrame
Aug, 2026 - Aug, 2027
description
Evaluation metrics include AUROC, sensitivity, specificity, positive predictive value, negative predictive value, and calibration.

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

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).

References

Publications (5)

RESULTLee 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 37452503
RESULTTruong 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 37723439
RESULTChun 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 37734683
RESULTShi 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 32998878
RESULTQiu 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 39556395

Registry

Dates and enrollment

Start: Aug 20, 2026
Primary completion: Aug 31, 2027
Completion: Dec 31, 2028
First posted: Aug 21, 2026
Last update posted: Aug 28, 2026
Enrollment: 2,000 (estimated)
Lead sponsor: Beijing Friendship Hospital OTHER
Collaborators: The Second Hospital & Clinical Medical School, Lanzhou University; Beijing Ditan Hospital; Yuncheng Central Hospital; Guangzhou Eighth People's Hospital, Guangzhou Medical University.
Keywords: HCC, Risk Prediction Model, Multimodal Data, Artificial Intelligence, Chronic Hepatitis B

Data updated 22 days agoSource updated Aug 28, 2026source: clinicaltrials

Locations

Locations by country (1)

Country	Sites	Recruiting
China	1	0

Trial listing is informational. Eligibility is decided by the study team; contact information is on ClinicalTrials.gov.