- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04348838
Prospective Cohort of Patients With Hepatocellular Carcinoma in France (CHIEF)
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Olivier Ganry, Pr
- Phone Number: (33)322668193
- Email: ganry.olivier@chu-amiens.fr
Study Contact Backup
- Name: Gérard DUCOURNAU, Ing
- Phone Number: (33)322088376
- Email: ducournau.gerard@chu-amiens.fr
Study Locations
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-
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Amiens, France, 80480
- Recruiting
- CHU Amiens
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Contact:
- Olivier Ganry, Pr
- Phone Number: (33)322668193
- Email: ganry.olivier@chu-amiens.fr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
from day 1 of inclusion, up to 5 years
|
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
|
from day 1 of inclusion, up to 5 years
|
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
|
from day 1 of inclusion, up to 5 years
|
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
|
from day 1 of inclusion, up to 5 years
|
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
|
from day 1 of inclusion, up to 5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Variation of adverse event rate of HCC treatments in clinical practice
Time Frame: from day 1 of inclusion, up to 5 years
|
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
Time Frame: 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
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Jean-Claude BARBARE, Pr, CHU Amiens
- Principal Investigator: Yves-Edouard HERPE, CHU Amiens
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PI2019_843_0023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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