Hepatocellular Carcinoma (HCC)NCT07780357
HCC Risk Prediction Model Based on Multimodal Data in Chronic Hepatitis B
An observational study of Hepatocellular Carcinoma (HCC), run by Beijing Friendship Hospital at 1 site in China.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma (HCC)
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 20 Aug 2026to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Beijing Friendship Hospital, Capital Medical University
Beijing, Xicheng, 100050
Jialing Zhou, 860+010-63138665, Jialingzhou2023@163.com
Junwei Li, lijuwei123@126.com
About this study
Official title: 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.
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.
- Conditions
- Hepatocellular Carcinoma (HCC)
- Being tested
- No intervention (observational study)
- Keywords
- HCC, Risk Prediction Model, Multimodal Data, Artificial Intelligence, Chronic Hepatitis B
- Medical subject headings
- Carcinoma, Hepatocellular, Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention (observational study)Other
No intervention (observational study)
| Study group | Role | What they receive |
|---|---|---|
| HCC group | Participants who developed HCC within 5 years after enrollment Receives: Other: No intervention (observational study) | |
| Non-HCC group | Participants who did not develop HCC within 5 years after enrollment Receives: Other: No intervention (observational study) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Aug, 2026 - Aug, 2028
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study start20 Aug 2026 (estimated)
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular Carcinoma (HCC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07780357
- Sponsor's protocol ID
- CFH-2026-1Q-1022
- Other IDs
- 2026-1Q-1022
- Status last verified
- Aug 2026
- First submitted
- 19 Aug 2026
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 37452503Truong 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 37723439Chun 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 37734683Shi 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 32998878Qiu 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
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Application of an HCC Risk Prediction Model Based on Multimodal Data in Chronic Hepatitis B
- ClinicalTrials.gov ID
- NCT07780357
- Acronym / sponsor ID
- CFH-2026-1Q-1022
- Conditions
- Hepatocellular Carcinoma (HCC)
- Keywords
- HCC, Risk Prediction Model, Multimodal Data, Artificial Intelligence, Chronic Hepatitis B
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Collaborators
- The Second Hospital & Clinical Medical School, Lanzhou University, Beijing Ditan Hospital, Yuncheng Central Hospital, Guangzhou Eighth People's Hospital, Guangzhou Medical University.
- Study start
- 20 Aug 2026 (estimated)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 21 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HCC group | – | Other: No intervention (observational study)Participants who developed HCC within 5 years after enrollment |
| Non-HCC group | – | Other: No intervention (observational study)Participants who did not develop HCC within 5 years after enrollment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention (observational study)No intervention (observational study) | Other | HCC group, Non-HCC group |
Primary outcome
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.
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Results publication: PubMed 37452503Lee 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.
- Results publication: PubMed 37723439Truong 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.
- Results publication: PubMed 37734683Chun 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.
- Results publication: PubMed 32998878Shi 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.
- Results publication: PubMed 39556395Qiu 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma (HCC), run by Beijing Friendship Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jialing Zhou (860+010-63138665, Jialingzhou2023@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: Aug, 2026 - Aug, 2027). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07780357, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.