HBV-related Liver CirrhosisNCT07160946
Risk Assessment for HBV-Related Liver Cancer
An observational study of HBV-related Liver Cirrhosis, run by Sun Yat-sen University at 1 site in China.
Trial summary
Liver cancer is a severe disease worldwide. The incidence and mortality rates of liver cancer in China is the highest in the world. This project aims to perform a prospective, multi-center, large sample cohort study for HBV related high-risk individuals. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- HBV-related Liver Cirrhosis
- What is being tested?
- AI folow-up system
- How many people
- 6,000 participants
- Where
- 1 siteChina
- Study dates
- 10 May 2025to 30 Dec 2032
- How long will I take part?
- 5 Years
- 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The diagnostic rate of stage I liver cancer in China (AJCC-7 TNM staging system) is 17.5%. It is planned to increase the diagnostic rate of stage I liver cancer by 50% through this project, reaching 26.3%, power=0.9, a=0.05. PASS software calculated that a total of 958 liver cancer patients need to be enrolled in both groups. It is known that the annual incidence of liver cancer in patients with hepatitis B cirrhosis is 3% -6%. If calculated by 4%, it is estimated that the patients will be enrolled in one year, followed up for five years, and the lost rate is 10%, 5470 patients will need to be enrolled. Ultimately, this study plans to enroll 6000 patients.
Who may be able to join
None listed.
Who cannot join
- (a).Diagnosed with malignant tumors; (b). Post liver transplantation; (c). Infected with HIV; (d). Expected survival time<1 year; (e). With marked organ dysfunctions(heart, brain, kidney, lung, endocrine system, blood, etc.) or psychiatric patients.
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, 1 recruiting
- Recruiting
Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510630
Bingliang Prof. Lin, +86-20-85252081, linbingl@mail.sysu.edu.cn
About this study
Official title: Research on Risk Assessment and Intervention of HBV-Related Liver Cancer Based on Multimodal Data Fusion
Liver cancer is a severe disease worldwide. The incidence and mortality rates of liver cancer in China is the highest in the world. This project aims to perform a prospective, multi-center, large sample cohort study for HBV related high-risk individuals. Based on multimodal data fusion and AI technique, stratified management and follow-up system are conducted for HBV-related high-risk populations of liver cancer, in order to improve the early diagnosis rate of liver cancer.
- Conditions
- HBV-related Liver Cirrhosis
- Being tested
- AI folow-up system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI folow-up systemOther
In AI follow-up group, patients will be followed up by an AI system.
| Study group | Role | What they receive |
|---|---|---|
| Routine follow-up group | Patients in this cohor will be followed up every 24 weeks (or every 8-12 weeks for extremely high-risk population) routinely. Alpha fetoprotein, PIVKA-II, liver imaging examination, liver function, et al will be performed for these patients at each follow-up point. | |
| AI system follow-up group | Patients in this cohor will be followed up every 24 weeks (or every 8-12 weeks for extremely high-risk population). Alpha fetoprotein, PIVKA-II, liver imaging examination, liver function, et al will be performed for these patients at each follow up point. An AI system will be used to manage follow-up patients. Receives: Other: AI folow-up system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and specific time of participants progressing to liver cancer
Number and specific time of participants progressing to liver cancer
Measured: 5 years
Secondary outcomes (1)
Survival time
Participants' survival time after being diagnosed with liver cancer.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start10 May 2025
- Primary completion30 Dec 2032 (estimated)
- Study completion30 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HBV-related Liver CirrhosisStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 6,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lin Bingliang, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07160946
- Sponsor's protocol ID
- Spark Liver Health
- Status last verified
- Jul 2025
- First submitted
- 2 Aug 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Shan T, Ran X, Li H, Feng G, Zhang S, Zhang X, Zhang L, Lu L, An L, Fu R, Sun K, Wang S, Chen R, Li L, Chen W, Wei W, Zeng H, He J. Disparities in stage at diagnosis for liver cancer in China. J Natl Cancer Cent. 2023 Jan 3;3(1):7-13. doi: 10.1016/j.jncc.2022.12.002. eCollection 2023 Mar.
PubMed 39036312Singh SP, Madke T, Chand P. Global Epidemiology of Hepatocellular Carcinoma. J Clin Exp Hepatol. 2025 Mar-Apr;15(2):102446. doi: 10.1016/j.jceh.2024.102446. Epub 2024 Oct 28.
PubMed 39659901
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on Risk Assessment and Intervention of HBV-Related Liver Cancer Based on Multimodal Data Fusion
- ClinicalTrials.gov ID
- NCT07160946
- Acronym / sponsor ID
- Spark Liver Health
- Conditions
- HBV-related Liver Cirrhosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 10 May 2025 (actual)
- Primary completion
- 30 Dec 2032 (estimated)
- Study completion
- 30 Dec 2032 (estimated)
- First posted
- 8 Sep 2025 (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.
Liver cancer is a severe disease worldwide. The incidence and mortality rates of liver cancer in China is the highest in the world. This project aims to perform a prospective, multi-center, large sample cohort study for HBV related high-risk individuals. Based on multimodal data fusion and AI technique, stratified management and follow-up system are conducted for HBV-related high-risk populations of liver cancer, in order to improve the early diagnosis rate of liver cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine follow-up group | – | –Patients in this cohor will be followed up every 24 weeks (or every 8-12 weeks for extremely high-risk population) routinely. Alpha fetoprotein, PIVKA-II, liver imaging examination, liver function, et al will be performed for these patients at each follow-up point. |
| AI system follow-up group | – | Other: AI folow-up systemPatients in this cohor will be followed up every 24 weeks (or every 8-12 weeks for extremely high-risk population). Alpha fetoprotein, PIVKA-II, liver imaging examination, liver function, et al will be performed for these patients at each follow up point. An AI system will be used to manage follow-up patients. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The diagnostic rate of stage I liver cancer in China (AJCC-7 TNM staging system) is 17.5%. It is planned to increase the diagnostic rate of stage I liver cancer by 50% through this project, reaching 26.3%, power=0.9, a=0.05. PASS software calculated that a total of 958 liver cancer patients need to be enrolled in both groups. It is known that the annual incidence of liver cancer in patients with hepatitis B cirrhosis is 3% -6%. If calculated by 4%, it is estimated that the patients will be enrolled in one year, followed up for five years, and the lost rate is 10%, 5470 patients will need to be enrolled. Ultimately, this study plans to enroll 6000 patients.
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- (a).Diagnosed with malignant tumors; (b). Post liver transplantation; (c). Infected with HIV; (d). Expected survival time<1 year; (e). With marked organ dysfunctions(heart, brain, kidney, lung, endocrine system, blood, etc.) or psychiatric patients.
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 |
|---|---|---|
| AI folow-up systemIn AI follow-up group, patients will be followed up by an AI system. | Other | AI system follow-up group |
Primary outcome
Number and specific time of participants progressing to liver cancer
Time frame: 5 years
Number and specific time of participants progressing to liver cancer
1 secondary outcome
Survival time
Time frame: 5 years
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 8 Sep 2025.
- Results publication: PubMed 39036312Shan T, Ran X, Li H, Feng G, Zhang S, Zhang X, Zhang L, Lu L, An L, Fu R, Sun K, Wang S, Chen R, Li L, Chen W, Wei W, Zeng H, He J. Disparities in stage at diagnosis for liver cancer in China. J Natl Cancer Cent. 2023 Jan 3;3(1):7-13. doi: 10.1016/j.jncc.2022.12.002. eCollection 2023 Mar.
- Results publication: PubMed 39659901Singh SP, Madke T, Chand P. Global Epidemiology of Hepatocellular Carcinoma. J Clin Exp Hepatol. 2025 Mar-Apr;15(2):102446. doi: 10.1016/j.jceh.2024.102446. Epub 2024 Oct 28.
- Related InfoLink provided by the sponsor.
Related trials for HBV-related Liver Cirrhosis
RecruitingPhase 2
Liver Cirrhosis Network Rosuvastatin Efficacy and Safety for Cirrhosis in the United States
Cirrhosis, Cirrhosis, Liver
Active, not recruitingObservational study
Clinical Characteristics of Recompensation
Cirrhosis, Alcohol Related Liver Disease
Not yet recruiting
Effect of Babao Dan Capsule Combined With Antiviral Therapy on the Incidence of Hepatocellular Carcinoma in Patients With Hepatitis B-related Cirrhosis
HEPATITIS B CHRONIC, Cirrhosis, Liver
Not yet recruiting
Effect of Fufang Biejiaruangan Combined With Antiviral Therapy on the Incidence of Hepatocellular Carcinoma in Patients With Hepatitis B-related Cirrhosis: A Multicenter, Randomized, Placebo-controlled Study
Cirrhosis, Liver, Hepatocellular Carcinoma (HCC)
Not yet recruitingObservational study
Hepatic and Splenic Microcirculatory Perfusion for Ruling Out High-Risk Varices in Patients With Hepatitis B-Related Cirrhosis
Hepatitis B Virus Related Cirrhosis, Portal Hypertension Related to Cirrhosis
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 HBV-related Liver Cirrhosis, run by Sun Yat-sen University 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 0 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 8 Sep 2025. 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 Bingliang Prof. Lin (+86-20-85252081, linbingl@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and specific time of participants progressing to liver cancer (time frame: 5 years). 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 NCT07160946, which also lists 2 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 8 Sep 2025.