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Not yet recruitingNCT07780357Updated Aug 28, 2026

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

An observational study in Hepatocellular Carcinoma (HCC), sponsored by Beijing Friendship Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-28.

Sponsored by Beijing Friendship Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
2,000
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Hepatocellular Carcinoma (HCC)

Keywords

  • HCC
  • Risk Prediction Model
  • Multimodal Data
  • Artificial Intelligence
  • Chronic Hepatitis B
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In context

Carcinoma, Hepatocellular

3,648 studies on the registry are indexed under Carcinoma, Hepatocellular; 1,061 are open to participants now.

This study's planned enrollment of 2,000 is above the median of 200 across 850 observational studies indexed under Carcinoma, Hepatocellular.

Browse Carcinoma, Hepatocellular studies →

Lead sponsor

Beijing Friendship Hospital is the lead sponsor of 217 studies on the registry; 94 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Aged ≥18 years, both sexes eligible.
  2. Diagnosed with -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

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 (except those considered cured).
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
2,000 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • HCC group

    Participants who developed HCC within 5 years after enrollment

    Other: No intervention (observational study)

  • Non-HCC group

    Participants who did not develop HCC within 5 years after enrollment

    Other: No intervention (observational study)

Interventions

  • OtherNo intervention (observational study)

    No intervention (observational study)

06

What researchers measure

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

07

Study locations

1 site
  • Beijing Friendship Hospital, Capital Medical University
    Beijing, Xicheng 100050, China
    • Jialing Zhou · ContactJialingzhou2023@163.com · 860+010-63138665
    • Junwei Li · Contactlijuwei123@126.com
    • 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 · Principal investigator
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References and documents

Publications

  • 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. PubMed 37452503 ↗
  • Truong 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. PubMed 37723439 ↗
  • Chun 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. PubMed 37734683 ↗
  • Shi 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. PubMed 32998878 ↗
  • Qiu 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. PubMed 39556395 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07780357
Collaborators
The Second Hospital & Clinical Medical School, Lanzhou University, Beijing Ditan Hospital, Yuncheng Central Hospital, Guangzhou Eighth People's Hospital, Guangzhou Medical University.
Responsible party
Sponsor
First posted
Aug 21, 2026
Start date
Aug 20, 2026 (estimated)
Primary completion
Aug 31, 2027 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Aug 28, 2026

Study contacts

Jialing Zhou
Contact
Jialingzhou2023@163.com
860+010-63138665

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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