Prospective Cohort of Patients With Hepatocellular Carcinoma in France

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04348838

Acronym

CHIEF

Enrollment

5000

Registered

2020-04-16

Start date

2019-09-26

Completion date

2027-12-31

Last updated

2025-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer of Liver, Hepatocellular Carcinoma

Keywords

cancer, liver, hepatocellular carcinoma, cohort

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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 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
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 overall survival time (OS) after chemoembolization	from day 1 of inclusion, up to 5 years	Variation of overall survival time (OS) after chemoembolization

Secondary

Measure	Time frame	Description
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
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

Countries

France

Contacts

Primary ContactOlivier Ganry, Pr

ganry.olivier@chu-amiens.fr(33)322668193

Backup ContactGérard DUCOURNAU, Ing

ducournau.gerard@chu-amiens.fr(33)322088376

Outcome results