Prospective Surveillance for Very Early Hepatocellular Carcinoma

Overview

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.

Full Title of Study: “Prospective Surveillance for Very Early Hepatocellular Carcinoma (PRECAR): an Observational Cohort Trial”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: July 15, 2022

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.

Arms, Groups and Cohorts

  • Cirrhosis cohort
    • Patients with liver cirrhosis.
  • HBV infection cohort
    • Patients with seropositivity of HBsAg.

Clinical Trial Outcome Measures

Primary Measures

  • Hepatocellular carcinoma
    • Time Frame: July 2018 to July 2022
    • Development of hepatocellular carcinoma
  • Overall survival
    • Time Frame: July 2018 to July 2022
    • Death
  • Liver-related disease progression
    • Time Frame: July 2018 to July 2022
    • HBV and cirrhosis progression

Secondary Measures

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

Participating in This Clinical Trial

Inclusion Criteria

- [1] Cirrhosis cohort 1. Age within 30 to 75 years. 2. Diagnosis of liver cirrhosis within recent 6 months. 1. Liver biopsy: Metavir score of 4 or Ishak score of 5 to 6. 2. No liver biopsy: Presence of ascites, hepatic encephalopathy, or variceal hemorrhage. 3. 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 1. Age within 40 to 70 years 2. Chronic HBV infection (seropositive for HBsAg over 6 months). Exclusion Criteria:

1. 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.

Gender Eligibility: All

Minimum Age: 30 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Eastern Hepatobiliary Surgery Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Lei Chen, PhD, Professor – Eastern Hepatobiliary Surgery Hospital
  • Overall Official(s)
    • Hongyang Wang, MD and PhD, Principal Investigator, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, Shanghai, China
    • Jinlin Hou, MD, Principal Investigator, Nanfang Hospital, Southern Medical University
  • Overall Contact(s)
    • Hongyang Wang, PhD, 86 21 81875361, hywangk@vip.sina.com

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