Prospective Cohort of Patients With Hepatocellular Carcinoma in France (CHIEF)

March 21, 2023 updated by: Centre Hospitalier Universitaire, Amiens

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.

Study Overview

Status

Recruiting

Study Type

Observational

Enrollment (Anticipated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Variation of progression free survival (PFS) in intent to treat after liver transplantation
Time Frame: from day 1 of inclusion, up to 5 years
Variation of progression free survival (PFS) in intent to treat after liver transplantation
from day 1 of inclusion, up to 5 years
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
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 overall survival time (OS) after chemoembolization
Time Frame: from day 1 of inclusion, up to 5 years
Variation of overall survival time (OS) after chemoembolization
from day 1 of inclusion, up to 5 years
Variation of overall survival time (OS) after radioembolization
Time Frame: from day 1 of inclusion, up to 5 years
Variation of overall survival time (OS) after radioembolization
from day 1 of inclusion, up to 5 years
Variation of overall survival time (OS) after pharmaceutical treatment
Time Frame: from day 1 of inclusion, up to 5 years
Variation of overall survival time (OS) after pharmaceutical treatment
from day 1 of inclusion, up to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Variation of adverse event rate of HCC treatments in clinical practice
Time Frame: from day 1 of inclusion, up to 5 years
Variation of 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
Time Frame: from day 1 of inclusion, up to 5 years
Variation of serious adverse event rate of HCC treatments in clinical practice
from day 1 of inclusion, up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 26, 2019

Primary Completion (Anticipated)

September 30, 2027

Study Completion (Anticipated)

December 31, 2027

Study Registration Dates

First Submitted

April 14, 2020

First Submitted That Met QC Criteria

April 14, 2020

First Posted (Actual)

April 16, 2020

Study Record Updates

Last Update Posted (Actual)

March 22, 2023

Last Update Submitted That Met QC Criteria

March 21, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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