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Recruiting Observational

Prospective Cohort of Patients With Hepatocellular Carcinoma in France

NCT04348838 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2019-09-26
Last updated
2025-06-10

Condition(s) studied

Cancer of LiverHepatocellular Carcinoma

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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 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 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

Trial sites (1)

FacilityCityRegionStatus
CHU Amiens Amiens France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04348838 on ClinicalTrials.gov ↗ ← All trials in France