Prospective Surveillance for Very Early Hepatocellular Carcinoma

Study Overview
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Brief Summary
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Hepatocellular carcinoma is one the leading cause of increasing cancer-specific mortality worldwide. Early diagnosis of hepatocellular carcinoma provides opportunity for curative therapeutic approaches and relatively favorable prognosis. Herein, we intended to establish a biosignature for early diagnosis of hepatocellular carcinoma and stratification of risk population for intensive follow-up by implementing biannual follow-up investigation and collecting peripheral blood samples for screening.

Detailed Description
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Patients will be recruited for 1 year and be follow-up for 3 years. Patients will make active hospital visit for collection of blood samples, which will be analyzed to develop a biosignature at the end of the study to detect very early hepatocellular carcinoma and stratify risk population for intensive follow-up.

Official Title
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Prospective Surveillance for Very Early Hepatocellular Carcinoma (PRECAR): an Observational Cohort Trial

Conditions
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Carcinoma, Hepatocellular

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - [1] Cirrhosis cohort Age within 30 to 75 years. Diagnosis of liver cirrhosis within recent 6 months. Liver biopsy: Metavir score of 4 or Ishak score of 5 to 6. No liver biopsy: Presence of ascites, hepatic encephalopathy, or variceal hemorrhage. Satisfying equal to or more than 2 of below conditions. Imaging studies indicating characteristics of liver cirrhosis: irregular liver surface, liver parenchyma particles or nodules, intraperitoneal collateral circulation, or varicose veins with or without splenomegaly (more than 4 cm or 5 ribs). Platelet count < 200 x 10^9/L. Alanine aminotransferase < 5 folds of normal level and liver hardness > 12 kPa. Gastroesophageal varices from endoscopy or imaging studies. [2] HBV infection cohort Age within 40 to 70 years Chronic HBV infection (seropositive for HBsAg over 6 months). Exclusion Criteria: Cirrhosis cohort (1) Child-Pugh score of C. (2) Hereditary metabolic liver diseases. (3) Presence of HIV-Ab. (4) Previous diagnosis of active pulmonary tuberculosis. (5) Diagnosis of malignant tumors before or during hospitalization, including but not limited to hepatocellular carcinoma. (6) Patients who had received allogeneic blood transfusion or cell therapy within 1 year. (7) Pregnant women. [2] HBV infection cohort (1) Autoimmune liver diseases. (2) Hereditary metabolic liver diseases. (3) Other chronic liver diseases, such as flukes. (4) Presence of HCV, HDV, HEV, or HIV infection. (5) Previous diagnosis of active pulmonary tuberculosis. (6) Diagnosis of malignant tumors before or during hospitalization, including but not limited to hepatocellular carcinoma. (7) Patients who had received allogeneic blood transfusion or cell therapy within 1 year. (8) Pregnant women.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cirrhosis cohort<br>Patients with liver cirrhosis. | |
| HBV infection cohort<br>Patients with seropositivity of HBsAg. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hepatocellular carcinoma | Development of hepatocellular carcinoma | July 2018 to July 2022 | 
| Overall survival | Death | July 2018 to July 2022 | 
| Liver-related disease progression | HBV and cirrhosis progression | July 2018 to July 2022 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-hepatocellular carcinoma malignant neoplasm | Development of other primary liver cancer, such as Intrahepatic cholangiocarcinoma. | July 2018 to July 2022 |