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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AI folow-up system | Other | In AI follow-up group, patients will be followed up by an AI system. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number and specific time of participants progressing to liver cancer | Number and specific time of participants progressing to liver cancer | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Survival time | Participants' survival time after being diagnosed with liver cancer. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events for the participants | Incidence of ascite, hepatorenal system, hepatic encephalopathy, gastrointestinal bleeding, etc. for all the participants. | 5 years |
Inclusion Criteria: must meet (a) and any one of (b) to (g).
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bingliang Prof. Lin | Contact | +86-20-85252081 | linbingl@mail.sysu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Third Affiliated Hospital of Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | 510630 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39036312 | Result | 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. | |
| 39659901 | Result | Singh 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. |
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| Related Info | View source |
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