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PRECAR: Prospective Surveillance for Very Early Hepatocellular Carcinoma

Sponsor
Eastern Hepatobiliary Surgery Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT03588442
Collaborator
(none)
10,000
Enrollment
13
Locations
60
Anticipated Duration (Months)
769.2
Patients Per Site
12.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    10000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Prospective Surveillance for Very Early Hepatocellular Carcinoma (PRECAR): an Observational Cohort Trial
    Actual Study Start Date :
    Jul 15, 2018
    Anticipated Primary Completion Date :
    Jul 15, 2022
    Anticipated Study Completion Date :
    Jul 15, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Cirrhosis cohort

    Patients with liver cirrhosis.
    HBV infection cohort

    Patients with seropositivity of HBsAg.

    Outcome Measures

    Primary Outcome Measures

    1. Hepatocellular carcinoma [July 2018 to July 2022]

      Development of hepatocellular carcinoma

    2. Overall survival [July 2018 to July 2022]

      Death

    3. Liver-related disease progression [July 2018 to July 2022]

      HBV and cirrhosis progression

    Secondary Outcome Measures

    1. Non-hepatocellular carcinoma malignant neoplasm [July 2018 to July 2022]

      Development of other primary liver cancer, such as Intrahepatic cholangiocarcinoma.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    [1] Cirrhosis cohort

    1. Age within 30 to 75 years.

    2. Diagnosis of liver cirrhosis within recent 6 months.

    3. Liver biopsy: Metavir score of 4 or Ishak score of 5 to 6.

    4. No liver biopsy: Presence of ascites, hepatic encephalopathy, or variceal hemorrhage.

    5. 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The First Hospital Affiliated to AMU (Southwest Hospital) Chongqing Chongqing China 400038
    2 Mengchao Hepatobiliary Surgery Hospital of Fujian Medical University Fuzhou Fujian China 350025
    3 Nanfang Hospital, Southern Medical University Guangzhou Guangdong China 510515
    4 The Central Hospital of Wuhan Wuhan Hubei China 430014
    5 Chifeng Municipal Hospital Chifeng Inner Mongolia China 024000
    6 Xuzhou No.1 People's Hospital Xuzhou Jiangsu China 221002
    7 Xuzhou Infectious Disease Hospital Xuzhou Jiangsu China 221004
    8 The First Bethune of Jilin University Changchun Jilin China 130021
    9 The Second Hospital of Shandong University Jinan Shandong China 250000
    10 Shanghai Public Health Clinical Center Shanghai Shanghai China 200000
    11 Shanghai Oriental Hepatobiliary Surgery Hospital Shanghai Shanghai China 200438
    12 First Affiliated Hospital, Xinjiang Medical University Ürümqi Xinjiang China 830054
    13 HwaMei Hospital, University of Chinese Academy of Sciences Ningbo Zhejiang China 315000

    Sponsors and Collaborators

    • Eastern Hepatobiliary Surgery Hospital

    Investigators

    • Principal Investigator: Hongyang Wang, MD and PhD, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, Shanghai, China
    • Principal Investigator: Jinlin Hou, MD, Nanfang Hospital of Southern Medical University

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Lei Chen, PhD, Professor, Eastern Hepatobiliary Surgery Hospital
    ClinicalTrials.gov Identifier:
    NCT03588442
    Other Study ID Numbers:
    • 2018ZX10732202
    First Posted:
    Jul 17, 2018
    Last Update Posted:
    May 22, 2020
    Last Verified:
    May 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Carcinoma
    Carcinoma, Hepatocellular

    Study Results

    No Results Posted as of May 22, 2020