Prospective Cohort of Patients With Hepatocellular Carcinoma in France

Hepatocellular Carcinoma Clinical Trial

— CHIEF  

Official title:

Prospective Cohort of Patients With Hepatocellular Carcinoma in France

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04348838
• Other study ID #: PI2019_843_0023
• Status: Recruiting
• Start date: August 26, 2019
• Est. completion date: December 31, 2027

Study information

• Verified date: March 2023
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: Olivier Ganry, Pr
• Phone: (33)322668193
• Email: ganry.olivier[@]chu-amiens.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: December 31, 2027
• Est. primary completion date: September 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer of Liver
• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Liver Neoplasms

Locations

Country	Name	City	State
France	CHU Amiens	Amiens

Sponsors (13)

Lead Sponsor

Collaborator

Centre Hospitalier Universitaire, Amiens

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

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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