Prospective Cohort of Patients With Hepatocellular Carcinoma in France
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Cancer of Liver, Hepatocellular Carcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- 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 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 overall survival time (OS) after chemoembolization [Time frame: 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 pharmaceutical treatment [Time frame: from day 1 of inclusion, up to 5 years]
Secondary outcome measures (2)
- Variation of 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 [Time frame: from day 1 of inclusion, up to 5 years]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- CHU Amiens — Amiens
Identifiers
NCT: NCT04348838 · PI2019_843_0023