Prospective Cohort of Patients With Hepatocellular Carcinoma in France

Study Overview
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Brief Summary
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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.

Official Title
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Prospective Cohort of Patients With Hepatocellular Carcinoma in France

Conditions
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Cancer of Liver, Hepatocellular Carcinoma

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation of progression free survival (PFS) in intent to treat after liver transplantation | 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 | 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 | 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 | 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 | 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 | 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 | Variation of serious adverse event rate of HCC treatments in clinical practice | from day 1 of inclusion, up to 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cancer, liver, hepatocellular carcinoma, cohort