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The goal of this study is to evaluate whether the standardized liver cancer risk stratification management can effectively improve the early diagnosis rate of liver cancer in the targeted risk population in China.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with very high risk for HCC according local guideline |
| ||
| Patients with high risk for HCC according local guideline |
| ||
| Patients with medium risk for HCC according local guideline |
| ||
| Patients with low risk for HCC according local guideline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liver cancer surveillance every 3 months | Behavioral | Follow up every 3 months for liver cancer surveillance, including but not limited to serum AFP test and ultrasound exam |
|
| Measure | Description | Time Frame |
|---|---|---|
| Early diagnosis rate of HCC patients | The proportion of patients who are first diagnosed with HCC at early stage to all the patients diagnosed as liver cancer in the study, from the start of the study to the completion of follow-up. Early diagnosis is defined as the patient with stage CNLC Ia, Ib and IIa. | Follow up up to three years for HCC occurance. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with regular follow-up | Regular follow-up is defined as the average difference between the actual treatment time and the theoretical treatment time equal or less than 1/3
|
| Measure | Description | Time Frame |
|---|---|---|
| The number of patients first diagnosed with liver cancer and the annual incidence rate | Four years collectively after the study started | |
| The number of patients first diagnosed with liver cancer and the annual incidence rate within each risk category | Four years collectively after the study started |
Inclusion Criteria:
Voluntary participation in the clinical study; fully informed about the study and signed informed consent, willing to follow and capable of completing all trial procedures[17]
Age: 18 to 75 years old (including the cut-offs)
Subjects must meet at least one of the following criteria for enrollment.
Patients diagnosed with chronic hepatitis B in hospital or out of hospital: persistent positive hepatitis B surface antigen (HBsAg) for 6 months or more
Patients diagnosed with hepatitis C in hospital or out of hospital
Patients diagnosed with cirrhosis in hospital or out of hospital who meet at least one of the following criteria.
Patients diagnosed with metabolic dysfunction-associated fatty liver disease (MAFLD) in hospital or out of hospital who have a liver fibrosis score of F3 or higher according to transient elastography, i.e., FibroScan® Liver Stiffness Measurement (LSM) ≥ 10 kPa or the corresponding FibroTouch® measurement threshold[18].
Patients diagnosed with MAFLD combined with abnormal glucose metabolism[19]
Subjects with a family history of liver cancer in their first-degree biological relatives.
Exclusion Criteria:
Patients meeting any of the following criteria will be excluded from the study:
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This study mainly includes the following risk groups of liver cancer: patients with chronic hepatitis B, patients with hepatitis C, patients with liver cirrhosis, patients with metabolic dysfunction-associated fatty liver disease (MAFLD) with a liver fibrosis index F3 or above, MAFLD patients combined with abnormal glucose metabolism, and people with a family history of liver cancer in their first-degree biological relatives.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qing Xie, MD | Contact | 0086-021-64370045 | 680403 | xieqingrjh@163.com |
| Honglian Gui, MD,PhD | Contact | 0086-021-64370045 | 680419 | lillian_ghl@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Infectious Diseases , Ruijin Hospital, Shanghai Jiao Tong University School of Medicine | Recruiting | Shanghai | Shanghai Municipality | China |
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| Liver cancer surveillance every 6 months | Behavioral | Follow up every 6 months for liver cancer surveillance, including but not limited to serum AFP test and ultrasound exam |
|
| Liver cancer surveillance annually | Behavioral | Follow up annually for liver cancer surveillance, including but not limited to serum AFP test and ultrasound exam |
|
| Four years collectively after the study started |
| The distribution of risk stratification of liver cancer in subjects at initial screening | The proportion of very high-risk, high-risk, medium-risk, and low-risk subjects to the whole subject population | Initial screening after enrollment |
| The distribution of risk stratification of liver cancer in subjects at the last follow-up visit or at the time of diagnosis of liver cancer | The proportion of very high-risk, high-risk, medium-risk and low-risk subjects to the whole subject population | Last follow-up visit or at the time of diagnosis of liver cancer up to three years of follow-up |
| Pooled 3-year cumulative incidence of liver cancer | Follow up up to 3 years |
| The early diagnosis rate of liver cancer in each subject category according to the risk stratification at initial screening | The early diagnosis rate of liver cancer of subjects with very high-risk, high-risk, medium-risk, and low-risk at initial screening, respectively | Initial screening after enrollment |
| The 3-year cumulative incidence of liver cancer in each subject category according to the risk stratification at the time of initial diagnosis | The 3-year cumulative incidence of liver cancer for subjects with very high-risk, high-risk, medium-risk, and low-risk, respectively | Four years collectively after the study started |
| The distribution of the CNLC staging of patients diagnosed as liver cancer first from the start of the study to the completion of follow-up | Four years collectively after the study started |
| The 3-year cumulative incidence of liver cancer in each disease subgroup | The disease types include but are not limited to hepatitis B, hepatitis C, cirrhosis, MAFLD | Follow up up to 3 years |
| Early diagnosis rate of HCC in each disease subgroup | The disease types include but are not limited to hepatitis B, hepatitis C, cirrhosis, MAFLD; early diagnosis of HCC is defined as the patient with stage CNLC Ia, Ib and IIa | Four years collectively after the study started |
| The compliance rate of each risk group defined at the initial risk stratification | The compliance rates for subjects with very high-risk, high-risk, medium-risk, and low-risk; the compliance rate is defined the same as above | Four years collectively after the study started |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| D019698 | Hepatitis C, Chronic |
| D019694 | Hepatitis B, Chronic |
| D008103 | Liver Cirrhosis |
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006509 | Hepatitis B |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D005355 | Fibrosis |
| D005234 | Fatty Liver |
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