Prospective Surveillance for Very Early Hepatocellular Carcinoma

Carcinoma, Hepatocellular Clinical Trial

— PRECAR  

Official title:

Prospective Surveillance for Very Early Hepatocellular Carcinoma (PRECAR): an Observational Cohort Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03588442
• Other study ID #: 2018ZX10732202
• Status: Recruiting
• Start date: July 15, 2018
• Est. completion date: July 15, 2023

Study information

• Verified date: May 2020
• Source: Eastern Hepatobiliary Surgery Hospital
• Contact: Hongyang Wang, PhD
• Phone: 86 21 81875361
• Email: hywangk[@]vip.sina.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: July 15, 2023
• Est. primary completion date: July 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular

Locations

Country	Name	City	State
China	The First Bethune of Jilin University	Changchun	Jilin
China	Chifeng Municipal Hospital	Chifeng	Inner Mongolia
China	The First Hospital Affiliated to AMU (Southwest Hospital)	Chongqing	Chongqing
China	Mengchao Hepatobiliary Surgery Hospital of Fujian Medical University	Fuzhou	Fujian
China	Nanfang Hospital, Southern Medical University	Guangzhou	Guangdong
China	The Second Hospital of Shandong University	Jinan	Shandong
China	HwaMei Hospital, University of Chinese Academy of Sciences	Ningbo	Zhejiang
China	Shanghai Oriental Hepatobiliary Surgery Hospital	Shanghai	Shanghai
China	Shanghai Public Health Clinical Center	Shanghai	Shanghai
China	First Affiliated Hospital, Xinjiang Medical University	Ürümqi	Xinjiang
China	The Central Hospital of Wuhan	Wuhan	Hubei
China	Xuzhou Infectious Disease Hospital	Xuzhou	Jiangsu
China	Xuzhou No.1 People's Hospital	Xuzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Eastern Hepatobiliary Surgery Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hepatocellular carcinoma	Development of hepatocellular carcinoma	July 2018 to July 2022
Primary	Overall survival	Death	July 2018 to July 2022
Primary	Liver-related disease progression	HBV and cirrhosis progression	July 2018 to July 2022
Secondary	Non-hepatocellular carcinoma malignant neoplasm	Development of other primary liver cancer, such as Intrahepatic cholangiocarcinoma.	July 2018 to July 2022