CHIEF: Prospective Cohort of Patients With Hepatocellular Carcinoma in France

Sponsor

Centre Hospitalier Universitaire, Amiens (Other)

Overall Status

Recruiting

CT.gov ID

NCT04348838

Collaborator

Biobanque de Picardie (Other), Société Nationale Française de Gastroentérologie (Other), Association Française pour l'Etude du Foie (AFEF) (Other), Federation Francophone de Cancerologie Digestive (Other), Association Nationale des Hépato-Gastroentérologues des Hôpitaux Généraux (ANGH) (Other), UNICANCER (Other), Groupe Coopérateur multidisciplinaire en Oncologie (GERCOR) (Other), Club de Réflexion des Cabinets et Groupes d'Hépato-Gastroentérologie (CREGG) (Other), Association de Chirurgie Hépato-Bilio-Pancréatique et de Transplantation (ACHBT) (Other), Société Française de Pathologie (SFP) (Other), Société Française de Radiologie (SFR) (Other), Societe Francaise de Radiotherapie Oncologique (Other)

5,000

Enrollment

Location

100.2

Anticipated Duration (Months)

49.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer of Liver Hepatocellular Carcinoma

Study Design

Study Type:

Observational

Anticipated Enrollment :

5000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Prospective Cohort of Patients With Hepatocellular Carcinoma in France

Actual Study Start Date :

Aug 26, 2019

Anticipated Primary Completion Date :

Sep 30, 2027

Anticipated Study Completion Date :

Dec 31, 2027

Outcome Measures

Primary Outcome Measures

Variation of progression free survival (PFS) in intent to treat after liver transplantation [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 [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 chemoembolization [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 [from day 1 of inclusion, up to 5 years]
Variation of overall survival time (OS) after radioembolization
Variation of overall survival time (OS) after pharmaceutical treatment [from day 1 of inclusion, up to 5 years]
Variation of overall survival time (OS) after pharmaceutical treatment

Secondary Outcome Measures

Variation of adverse event rate of HCC treatments in clinical practice [from day 1 of inclusion, up to 5 years]
Variation of 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]
Variation of serious adverse event rate of HCC treatments in clinical practice

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Amiens	Amiens		France	80480

Sponsors and Collaborators

Centre Hospitalier Universitaire, Amiens
Biobanque de Picardie
Société Nationale Française de Gastroentérologie
Association Française pour l'Etude du Foie (AFEF)
Federation Francophone de Cancerologie Digestive
Association Nationale des Hépato-Gastroentérologues des Hôpitaux Généraux (ANGH)
UNICANCER
Groupe Coopérateur multidisciplinaire en Oncologie (GERCOR)
Club de Réflexion des Cabinets et Groupes d'Hépato-Gastroentérologie (CREGG)
Association de Chirurgie Hépato-Bilio-Pancréatique et de Transplantation (ACHBT)
Société Française de Pathologie (SFP)
Société Française de Radiologie (SFR)
Societe Francaise de Radiotherapie Oncologique