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Prospective Surveillance for Very Early Hepatocellular Carcinoma (PRECAR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03588442
Recruitment Status : Recruiting
First Posted : July 17, 2018
Last Update Posted : May 22, 2020
Sponsor:
Information provided by (Responsible Party):
Lei Chen, PhD, Eastern Hepatobiliary Surgery Hospital

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
Carcinoma, Hepatocellular

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.

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Study Type : Observational
Estimated 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 : July 15, 2018
Estimated Primary Completion Date : July 15, 2022
Estimated Study Completion Date : July 15, 2023

Group/Cohort
Cirrhosis cohort
Patients with liver cirrhosis.
HBV infection cohort
Patients with seropositivity of HBsAg.



Primary Outcome Measures :
  1. Hepatocellular carcinoma [ Time Frame: July 2018 to July 2022 ]
    Development of hepatocellular carcinoma

  2. Overall survival [ Time Frame: July 2018 to July 2022 ]
    Death

  3. Liver-related disease progression [ Time Frame: July 2018 to July 2022 ]
    HBV and cirrhosis progression


Secondary Outcome Measures :
  1. Non-hepatocellular carcinoma malignant neoplasm [ Time Frame: July 2018 to July 2022 ]
    Development of other primary liver cancer, such as Intrahepatic cholangiocarcinoma.



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Cirrhosis cohort: patients with liver cirrhosis. HBV infection cohort: patients with chronic HBV infection.
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03588442


Contacts
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Contact: Hongyang Wang, PhD 86 21 81875361 hywangk@vip.sina.com
Contact: Lei Chen, PhD 86 13918939969 chenlei@smmu.edu.cn

Locations
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China, Chongqing
The First Hospital Affiliated to AMU (Southwest Hospital) Recruiting
Chongqing, Chongqing, China, 400038
Contact: Xiaomei Xiang, BM    15023263301    xiangxiaomei413@sina.cn   
China, Fujian
Mengchao Hepatobiliary Surgery Hospital of Fujian Medical University Recruiting
Fuzhou, Fujian, China, 350025
Contact: Xiaolong Liu, MD    13313975783    xiaoloong.liu@foxmail.com   
China, Guangdong
Nanfang Hospital, Southern Medical University Recruiting
Guangzhou, Guangdong, China, 510515
Contact: Rong Fan, MD    13143522264    rongfansmu@163.com   
China, Hubei
The Central Hospital of Wuhan Recruiting
Wuhan, Hubei, China, 430014
Contact: Min Du, PhD    15926366269    treacy29@163.com   
China, Inner Mongolia
Chifeng Municipal Hospital Recruiting
Chifeng, Inner Mongolia, China, 024000
Contact: Yanlong Yu, MM    15247666626    yuyanlong1895@163.com   
China, Jiangsu
Xuzhou No.1 People's Hospital Recruiting
Xuzhou, Jiangsu, China, 221002
Contact: Xiaoqian Liu, MM    13952173003    zbliuxiaoqian@126.com   
Xuzhou Infectious Disease Hospital Recruiting
Xuzhou, Jiangsu, China, 221004
Contact: Zhanzhong Liu, PhD    18352222280    Zhanzhong.liu@foxmail.com   
China, Jilin
The First Bethune of Jilin University Recruiting
Changchun, Jilin, China, 130021
Contact: Yanhang Gao, MD    15804303019    15804303019@163.com   
China, Shandong
The Second Hospital of Shandong University Recruiting
Jinan, Shandong, China, 250000
Contact: Lutao Du, MD    13573132466    dulutao1984@163.com   
China, Shanghai
Shanghai Public Health Clinical Center Recruiting
Shanghai, Shanghai, China, 200000
Contact: Jiao Liu, MD    18930328039    liujiao8812@163.com   
Shanghai Oriental Hepatobiliary Surgery Hospital Recruiting
Shanghai, Shanghai, China, 200438
Contact: Hui Wang, MD    13816444416    13816444416@163.com   
China, Xinjiang
First Affiliated Hospital, Xinjiang Medical University Recruiting
Ürümqi, Xinjiang, China, 830054
Contact: Hali Da, MM    18509914924    28043284@qq.com   
China, Zhejiang
HwaMei Hospital, University of Chinese Academy of Sciences Recruiting
Ningbo, Zhejiang, China, 315000
Contact: Xudong Zhao, MD    15990575156    zhaoxudong120@sina.com   
Sponsors and Collaborators
Eastern Hepatobiliary Surgery Hospital
Investigators
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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)

Documents provided by Lei Chen, PhD, Eastern Hepatobiliary Surgery Hospital:
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Responsible Party: Lei Chen, PhD, Professor, Eastern Hepatobiliary Surgery Hospital
ClinicalTrials.gov Identifier: NCT03588442    
Other Study ID Numbers: 2018ZX10732202
First Posted: July 17, 2018    Key Record Dates
Last Update Posted: May 22, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Carcinoma
Carcinoma, Hepatocellular
Adenocarcinoma
Digestive System Diseases
Liver Diseases