Prospective Surveillance for Very Early Hepatocellular Carcinoma

• Conditions: Carcinoma, Hepatocellular

• Registration Number: NCT03588442
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2018-07-01
• Study First Submitted QC: 2018-07-11
• Study Start: 2018-07-15
• Study First Posted: 2018-07-17
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-20
• Last Update Posted: 2020-05-22
• Primary Completion: 2022-07-15
• Study Completion: 2023-07-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (13)

The First Hospital Affiliated to AMU (Southwest Hospital); 🇨🇳 Chongqing, Chongqing, China

Nanfang Hospital, Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China

Mengchao Hepatobiliary Surgery Hospital of Fujian Medical University; 🇨🇳 Fuzhou, Fujian, China

The Central Hospital of Wuhan; 🇨🇳 Wuhan, Hubei, China

Chifeng Municipal Hospital; 🇨🇳 Chifeng, Inner Mongolia, China

Xuzhou No.1 People's Hospital; 🇨🇳 Xuzhou, Jiangsu, China

Xuzhou Infectious Disease Hospital; 🇨🇳 Xuzhou, Jiangsu, China

The Second Hospital of Shandong University; 🇨🇳 Jinan, Shandong, China

Shanghai Public Health Clinical Center; 🇨🇳 Shanghai, Shanghai, China

The First Bethune of Jilin University; 🇨🇳 Changchun, Jilin, China

First Affiliated Hospital, Xinjiang Medical University; 🇨🇳 Ürümqi, Xinjiang, China

HwaMei Hospital, University of Chinese Academy of Sciences; 🇨🇳 Ningbo, Zhejiang, China

Shanghai Oriental Hepatobiliary Surgery Hospital; 🇨🇳 Shanghai, Shanghai, China