Prospective Surveillance for Very Early Hepatocellular Carcinoma (PRECAR): an Observational Cohort Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 10,000
- 试验地点
- 13
- 主要终点
- Hepatocellular carcinoma
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •[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.
- •[2] HBV infection cohort
- •Age within 40 to 70 years
- •Chronic HBV infection (seropositive for HBsAg over 6 months).
排除标准
- •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.
结局指标
主要结局
Hepatocellular carcinoma
时间窗: July 2018 to July 2022
Development of hepatocellular carcinoma
Liver-related disease progression
时间窗: July 2018 to July 2022
HBV and cirrhosis progression
Overall survival
时间窗: July 2018 to July 2022
Death
次要结局
- Non-hepatocellular carcinoma malignant neoplasm(July 2018 to July 2022)
研究者
Lei Chen, PhD
Professor
Eastern Hepatobiliary Surgery Hospital