Prospective Cohort of Patients With Hepatocellular Carcinoma in France

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire, Amiens

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

New cases of HCC

suspected case of HCC regardless of the cause, stage, treatment

Known HCC: drug treatment for recurrence or progression

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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

Time frame
from day 1 of inclusion, up to 5 years
2

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

Time frame
from day 1 of inclusion, up to 5 years
3

Variation of overall survival time (OS) after chemoembolization

Variation of overall survival time (OS) after chemoembolization

Time frame
from day 1 of inclusion, up to 5 years
4

Variation of overall survival time (OS) after radioembolization

Variation of overall survival time (OS) after radioembolization

Time frame
from day 1 of inclusion, up to 5 years

Secondary outcomes

1

Variation of adverse event rate of HCC treatments in clinical practice

Variation of adverse event rate of HCC treatments in clinical practice

Time frame
from day 1 of inclusion, up to 5 years
2

Variation of serious adverse event rate of HCC treatments in clinical practice

Variation of serious adverse event rate of HCC treatments in clinical practice

Time frame
from day 1 of inclusion, up to 5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre Hospitalier Universitaire, Amiens

Lead sponsor

Biobanque de Picardie

Collaborator

Société Nationale Française de Gastroentérologie

Collaborator

Association Française pour l'Etude du Foie (AFEF)

Collaborator

Federation Francophone de Cancerologie Digestive

Collaborator

Association Nationale des Hépato-Gastroentérologues des Hôpitaux Généraux (ANGH)

Collaborator

UNICANCER

Collaborator

Groupe Coopérateur multidisciplinaire en Oncologie (GERCOR)

Collaborator

Club de Réflexion des Cabinets et Groupes d'Hépato-Gastroentérologie (CREGG)

Collaborator

Association de Chirurgie Hépato-Bilio-Pancréatique et de Transplantation (ACHBT)

Collaborator

Société Française de Pathologie (SFP)

Collaborator

Société Française de Radiologie (SFR)

Collaborator

Societe Francaise de Radiotherapie Oncologique

Collaborator