Clinical trial NCT04348838: Prospective Cohort of Patients With Hepatocellular Carcinoma in France
Official title: Prospective Cohort of Patients With Hepatocellular Carcinoma in France
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer of Liver
Hepatocellular Carcinoma
Keywords: cancer
liver
hepatocellular carcinoma
cohort
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
Collaborators: name: Biobanque de Picardie
name: Société Nationale Française de Gastroentérologie
name: Association Française pour l'Etude du Foie (AFEF)
name: Federation Francophone de Cancerologie Digestive
name: Association Nationale des Hépato-Gastroentérologues des Hôpitaux Généraux (ANGH)
name: UNICANCER
name: Groupe Coopérateur multidisciplinaire en Oncologie (GERCOR)
name: Club de Réflexion des Cabinets et Groupes d'Hépato-Gastroentérologie (CREGG)
name: Association de Chirurgie Hépato-Bilio-Pancréatique et de Transplantation (ACHBT)
name: Société Française de Pathologie (SFP)
name: Société Française de Radiologie (SFR)
name: Societe Francaise de Radiotherapie Oncologique
First posted: 2020-04-16
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population is including new case patients of HCC regardless of the cause, stage of the disease and treatment, and patients with known HCC.

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.


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

Primary outcomes:
measure: Variation of progression free survival (PFS) in intent to treat after liver transplantation
timeFrame: from day 1 of inclusion, up to 5 years
measure: Variation of time until failure of the strategy after hepatic resection and percutaneous destruction
timeFrame: from day 1 of inclusion, up to 5 years
measure: Variation of overall survival time (OS) after chemoembolization
timeFrame: from day 1 of inclusion, up to 5 years
measure: Variation of overall survival time (OS) after radioembolization
timeFrame: from day 1 of inclusion, up to 5 years
measure: Variation of overall survival time (OS) after pharmaceutical treatment
timeFrame: from day 1 of inclusion, up to 5 years
Secondary outcomes:
measure: Variation of adverse event rate of HCC treatments in clinical practice
timeFrame: from day 1 of inclusion, up to 5 years
measure: Variation of serious adverse event rate of HCC treatments in clinical practice
timeFrame: from day 1 of inclusion, up to 5 years
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
affiliation: CHU Amiens
name: Jean-Claude BARBARE, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Amiens
name: Yves-Edouard HERPE
role: PRINCIPAL_INVESTIGATOR
References: