Prospective Cohort of Patients With Hepatocellular Carcinoma in France

Recruiting

• Conditions: Cancer of Liver; Hepatocellular Carcinoma

• Registration Number: NCT04348838
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

Brief Summary

Hepatocellular carcinoma (HCC) occurs in 90% of cirrhosis primary liver cancers. In France, 8,500 new cases of HCC occur each year, and about 8,000 deaths per year are related to this cancer. The 5-year survival rate is 10%, one of the lowest survival rates of all cancer types. HCC raises a number of major challenges: HCC is discovered at a curable stage in only 25% of cases, reflecting the marked delay in the diagnosis of early stages. The state of knowledge about HCC is well behind that of other cancers (no biomarker, complex carcinogenesis, influence of the aetiology, poorly valorised data, etc.). Rapid technological progress requires large-scale studies to evaluate new diagnostic and therapeutic modalities.

The CHIEF project constitutes a common basis knowledge for research project using prospectively collected data in patients with HCC, regardless of the cause and stage of the cancer.

This project is a Multicentre longitudinal observational study of patients with HCC with prospective data collection on inclusion and patient follow-up. Constitution of a biological resources collection. 5,000 patients will be included over 2 years with a follow-up of patients of 5 years.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-26
• Study First Submitted: 2020-04-14
• Study First Submitted QC: 2020-04-14
• Study First Posted: 2020-04-16
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-05
• Last Update Posted: 2025-06-10
• Primary Completion: 2027-09-30
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

• New cases of HCC
• suspected case of HCC regardless of the cause, stage, treatment
• Known HCC: drug treatment for recurrence or progression

Exclusion Criteria

• Associated serious condition threatening life in the short term (with the exception of liver disease itself)
• So-called vulnerable populations: minors, persons under guardianship or temporary guardianship, or person deprived of their liberty by an administrative or judicial decision

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Variation of overall survival time (OS) after chemoembolization	from day 1 of inclusion, up to 5 years	Variation of overall survival time (OS) after chemoembolization
Variation of overall survival time (OS) after radioembolization	from day 1 of inclusion, up to 5 years	Variation of overall survival time (OS) after radioembolization
Variation of progression free survival (PFS) in intent to treat after liver transplantation	from day 1 of inclusion, up to 5 years	Variation of progression free survival (PFS) in intent to treat after liver transplantation
Variation of time until failure of the strategy after hepatic resection and percutaneous destruction	from day 1 of inclusion, up to 5 years	Variation of time until failure of the strategy after hepatic resection and percutaneous destruction
Variation of overall survival time (OS) after pharmaceutical treatment	from day 1 of inclusion, up to 5 years	Variation of overall survival time (OS) after pharmaceutical treatment

Secondary Outcome Measures

Name	Time	Method
Variation of adverse event rate of HCC treatments in clinical practice	from day 1 of inclusion, up to 5 years	Variation of adverse event rate of HCC treatments in clinical practice
Variation of serious adverse event rate of HCC treatments in clinical practice	from day 1 of inclusion, up to 5 years	Variation of serious adverse event rate of HCC treatments in clinical practice

Trial Locations

Locations (1)

CHU Amiens; 🇫🇷 Amiens, France