Clinical trial NCT03588442: Prospective Surveillance for Very Early Hepatocellular Carcinoma
Official title: Prospective Surveillance for Very Early Hepatocellular Carcinoma (PRECAR): an Observational Cohort Trial
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Carcinoma, Hepatocellular
Lead sponsor: Eastern Hepatobiliary Surgery Hospital
Sponsor class: OTHER
First posted: 2018-07-17
Enrollment: 10000
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Cirrhosis cohort: patients with liver cirrhosis. HBV infection cohort: patients with chronic HBV infection.

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.

Eligibility criteria: Inclusion Criteria:

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\[1\] Cirrhosis cohort

1. Age within 30 to 75 years.
2. Diagnosis of liver cirrhosis within recent 6 months.

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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.

Primary outcomes:
measure: Hepatocellular carcinoma
timeFrame: July 2018 to July 2022
measure: Overall survival
timeFrame: July 2018 to July 2022
measure: Liver-related disease progression
timeFrame: July 2018 to July 2022
Secondary outcomes:
measure: Non-hepatocellular carcinoma malignant neoplasm
timeFrame: July 2018 to July 2022
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The First Hospital Affiliated to AMU (Southwest Hospital)
state: Chongqing
city: Fuzhou
country: China
facility: Mengchao Hepatobiliary Surgery Hospital of Fujian Medical University
state: Fujian
city: Guangzhou
country: China
facility: Nanfang Hospital, Southern Medical University
state: Guangdong
city: Wuhan
country: China
facility: The Central Hospital of Wuhan
state: Hubei
city: Chifeng
country: China
facility: Chifeng Municipal Hospital
state: Inner Mongolia
city: Xuzhou
country: China
facility: Xuzhou No.1 People's Hospital
state: Jiangsu
city: Xuzhou
country: China
facility: Xuzhou Infectious Disease Hospital
state: Jiangsu
city: Changchun
country: China
facility: The First Bethune of Jilin University
state: Jilin
city: Jinan
country: China
facility: The Second Hospital of Shandong University
state: Shandong
city: Shanghai
country: China
facility: Shanghai Public Health Clinical Center
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Oriental Hepatobiliary Surgery Hospital
state: Shanghai
city: Ürümqi
country: China
facility: First Affiliated Hospital, Xinjiang Medical University
state: Xinjiang
city: Ningbo
country: China
facility: HwaMei Hospital, University of Chinese Academy of Sciences
state: Zhejiang
Study officials:
affiliation: Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, Shanghai, China
name: Hongyang Wang, MD and PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nanfang Hospital, Southern Medical University
name: Jinlin Hou, MD
role: PRINCIPAL_INVESTIGATOR
References: