Prospective Surveillance for Very Early Hepatocellular Carcinoma (PRECAR)

Naval Military Medical University (Second Military Medical University)

Status: Unknown

Conditions: Carcinoma, Hepatocellular

Study type: Observational

Funder types: Other

Identifiers

NCT03588442

2018ZX10732202

Details and patient eligibility

About

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 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.

Enrollment: 10,000 estimated patients

Sex: All

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

[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.

Trial design

10,000 participants in 2 patient groups

Cirrhosis cohort

Description:

Patients with liver cirrhosis.

HBV infection cohort

Description:

Patients with seropositivity of HBsAg.