Prospective Surveillance for Very Early Hepatocellular Carcinoma
PRECAR
1 other identifier
observational
10,000
1 country
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2018
Longer than P75 for all trials
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 1, 2018
CompletedStudy Start
First participant enrolled
July 15, 2018
CompletedFirst Posted
Study publicly available on registry
July 17, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 15, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 15, 2023
CompletedMay 22, 2020
May 1, 2020
4 years
July 1, 2018
May 20, 2020
Conditions
Outcome Measures
Primary Outcomes (3)
Hepatocellular carcinoma
Development of hepatocellular carcinoma
July 2018 to July 2022
Overall survival
Death
July 2018 to July 2022
Liver-related disease progression
HBV and cirrhosis progression
July 2018 to July 2022
Secondary Outcomes (1)
Non-hepatocellular carcinoma malignant neoplasm
July 2018 to July 2022
Study Arms (2)
Cirrhosis cohort
Patients with liver cirrhosis.
HBV infection cohort
Patients with seropositivity of HBsAg.
Eligibility Criteria
Cirrhosis cohort: patients with liver cirrhosis. HBV infection cohort: patients with chronic HBV infection.
You may qualify if:
- \[1\] Cirrhosis cohort
- Age within 30 to 75 years.
- Diagnosis of liver cirrhosis within recent 6 months.
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- Liver biopsy: Metavir score of 4 or Ishak score of 5 to 6.
- No liver biopsy: Presence of ascites, hepatic encephalopathy, or variceal hemorrhage.
- 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
- Age within 40 to 70 years
- Chronic HBV infection (seropositive for HBsAg over 6 months).
You may not qualify if:
- 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.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
The First Hospital Affiliated to AMU (Southwest Hospital)
Chongqing, Chongqing Municipality, 400038, China
Mengchao Hepatobiliary Surgery Hospital of Fujian Medical University
Fuzhou, Fujian, 350025, China
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515, China
The Central Hospital of Wuhan
Wuhan, Hubei, 430014, China
Chifeng Municipal Hospital
Chifeng, Inner Mongolia, 024000, China
Xuzhou No.1 People's Hospital
Xuzhou, Jiangsu, 221002, China
Xuzhou Infectious Disease Hospital
Xuzhou, Jiangsu, 221004, China
The First Bethune of Jilin University
Changchun, Jilin, 130021, China
The Second Hospital of Shandong University
Jinan, Shandong, 250000, China
Shanghai Public Health Clinical Center
Shanghai, Shanghai Municipality, 200000, China
Shanghai Oriental Hepatobiliary Surgery Hospital
Shanghai, Shanghai Municipality, 200438, China
First Affiliated Hospital, Xinjiang Medical University
Ürümqi, Xinjiang, 830054, China
HwaMei Hospital, University of Chinese Academy of Sciences
Ningbo, Zhejiang, 315000, China
Related Publications (1)
Xing X, Cai L, Ouyang J, Wang F, Li Z, Liu M, Wang Y, Zhou Y, Hu E, Huang C, Wu L, Liu J, Liu X. Proteomics-driven noninvasive screening of circulating serum protein panels for the early diagnosis of hepatocellular carcinoma. Nat Commun. 2023 Dec 18;14(1):8392. doi: 10.1038/s41467-023-44255-2.
PMID: 38110372DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hongyang Wang, MD and PhD
Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, Shanghai, China
- PRINCIPAL INVESTIGATOR
Jinlin Hou, MD
Nanfang Hospital, Southern Medical University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 1, 2018
First Posted
July 17, 2018
Study Start
July 15, 2018
Primary Completion
July 15, 2022
Study Completion
July 15, 2023
Last Updated
May 22, 2020
Record last verified: 2020-05