Prospective Surveillance for Very Early Hepatocellular Carcinoma (PRECAR): an Observational Cohort Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Carcinoma, Hepatocellular
- Sponsor
- Eastern Hepatobiliary Surgery Hospital
- Enrollment
- 10000
- Locations
- 13
- Primary Endpoint
- Hepatocellular carcinoma
- Last Updated
- 5 years ago
Overview
Brief Summary
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
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.
Investigators
Lei Chen, PhD
Professor
Eastern Hepatobiliary Surgery Hospital
Eligibility Criteria
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
- •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.
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.
Outcomes
Primary Outcomes
Hepatocellular carcinoma
Time Frame: July 2018 to July 2022
Development of hepatocellular carcinoma
Liver-related disease progression
Time Frame: July 2018 to July 2022
HBV and cirrhosis progression
Overall survival
Time Frame: July 2018 to July 2022
Death
Secondary Outcomes
- Non-hepatocellular carcinoma malignant neoplasm(July 2018 to July 2022)