Skip to main content
Clinical Trials/NCT04348838
NCT04348838
Recruiting
Not Applicable

Prospective Cohort of Patients With Hepatocellular Carcinoma in France

Centre Hospitalier Universitaire, Amiens1 site in 1 country5,000 target enrollmentSeptember 26, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cancer of Liver
Sponsor
Centre Hospitalier Universitaire, Amiens
Enrollment
5000
Locations
1
Primary Endpoint
Variation of overall survival time (OS) after chemoembolization
Status
Recruiting
Last Updated
10 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 26, 2019
End Date
December 31, 2027
Last Updated
10 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Variation of overall survival time (OS) after chemoembolization

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: from day 1 of inclusion, up to 5 years

Variation of overall survival time (OS) after pharmaceutical treatment

Secondary Outcomes

  • Variation of 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(from day 1 of inclusion, up to 5 years)

Study Sites (1)

Loading locations...

Similar Trials