NCT04348838

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
20mo left

Started Sep 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress80%
Sep 2019Dec 2027

Study Start

First participant enrolled

September 26, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 14, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 16, 2020

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

June 10, 2025

Status Verified

June 1, 2025

Enrollment Period

8 years

First QC Date

April 14, 2020

Last Update Submit

June 5, 2025

Conditions

Cancer of LiverHepatocellular Carcinoma

Keywords

cancerliverhepatocellular carcinomacohort

Outcome Measures

Primary Outcomes (5)

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (2)

  • 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

    from day 1 of inclusion, up to 5 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • New cases of HCC
  • suspected case of HCC regardless of the cause, stage, treatment
  • Known HCC: drug treatment for recurrence or progression

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens

Amiens, 80480, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Hepatic tissues, blood, urine and stools

MeSH Terms

Conditions

Liver NeoplasmsCarcinoma, HepatocellularNeoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Jean-Claude BARBARE, Pr

    CHU Amiens

    PRINCIPAL INVESTIGATOR

  • Yves-Edouard HERPE

    CHU Amiens

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Olivier Ganry, Pr

CONTACT

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

Gérard DUCOURNAU, Ing

CONTACT

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2020

First Posted

April 16, 2020

Study Start

September 26, 2019

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

June 10, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)