Cancer of LiverCHIEFNCT04348838
Prospective Cohort of Patients With Hepatocellular Carcinoma in France
An observational study of Cancer of Liver and Hepatocellular Carcinoma, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer of Liver, Hepatocellular Carcinoma
- How many people
- 5,000 participants
- Where
- 1 siteFrance
- Study dates
- 26 Sep 2019to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- New cases of HCC
- suspected case of HCC regardless of the cause, stage, treatment
- Known HCC: drug treatment for recurrence or progression
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Amiens
Amiens, 80480
Olivier Ganry, Pr, (33)322668193, ganry.olivier@chu-amiens.fr
About this study
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.
- Conditions
- Cancer of Liver, Hepatocellular Carcinoma
- Keywords
- cancer, liver, hepatocellular carcinoma, cohort
- Medical subject headings
- Liver Neoplasms, Carcinoma, Hepatocellular, Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: from day 1 of inclusion, up to 5 years
Secondary outcomes (2)
Variation of adverse event rate of HCC treatments in clinical practice
Variation of adverse event rate of HCC treatments in clinical practice
Measured: from day 1 of inclusion, up to 5 years
Variation of serious adverse event rate of HCC treatments in clinical practice
Variation of serious adverse event rate of HCC treatments in clinical practice
Measured: from day 1 of inclusion, up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2020
- Study start26 Sep 2019
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of LiverStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Collaborators
- Biobanque de Picardie, Société Nationale Française de Gastroentérologie, French Association for the Study of the Liver, Federation Francophone de Cancerologie Digestive, Association Nationale des Hépato-Gastroentérologues des Hôpitaux Généraux (ANGH), UNICANCER, Groupe Coopérateur multidisciplinaire en Oncologie (GERCOR), Club de Réflexion des Cabinets et Groupes d'Hépato-Gastroentérologie (CREGG), Association de Chirurgie Hépato-Bilio-Pancréatique et de Transplantation (ACHBT), Société Française de Pathologie (SFP), Société Française de Radiologie (SFR), Societe Francaise de Radiotherapie Oncologique
- Responsible party
- Sponsor
- Investigators
- Jean-Claude BARBARE, Pr, Principal investigator, CHU AmiensYves-Edouard HERPE, Principal investigator, CHU Amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04348838
- Sponsor's protocol ID
- PI2019_843_0023
- Acronym
- CHIEF
- Status last verified
- Jun 2025
- First submitted
- 14 Apr 2020
- Last updated
- 10 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort of Patients With Hepatocellular Carcinoma in France
- ClinicalTrials.gov ID
- NCT04348838
- Acronym / sponsor ID
- CHIEF / PI2019_843_0023
- Conditions
- Cancer of Liver, Hepatocellular Carcinoma
- Keywords
- cancer, liver, hepatocellular carcinoma, cohort
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Collaborators
- Biobanque de Picardie, Société Nationale Française de Gastroentérologie, French Association for the Study of the Liver, Federation Francophone de Cancerologie Digestive, Association Nationale des Hépato-Gastroentérologues des Hôpitaux Généraux (ANGH), UNICANCER, Groupe Coopérateur multidisciplinaire en Oncologie (GERCOR), Club de Réflexion des Cabinets et Groupes d'Hépato-Gastroentérologie (CREGG), Association de Chirurgie Hépato-Bilio-Pancréatique et de Transplantation (ACHBT), Société Française de Pathologie (SFP), Société Française de Radiologie (SFR), Societe Francaise de Radiotherapie Oncologique
- Study start
- 26 Sep 2019 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 16 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- New cases of HCC
- suspected case of HCC regardless of the cause, stage, treatment
- Known HCC: drug treatment for recurrence or progression
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
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
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
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
2 secondary outcomes
Variation of 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
Time frame: from day 1 of inclusion, up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jean-Claude BARBARE, Pr principal investigator
CHU Amiens
Yves-Edouard HERPE principal investigator
CHU Amiens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer of Liver and Hepatocellular Carcinoma, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Olivier Ganry, Pr ((33)322668193, ganry.olivier@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation of progression free survival (PFS) in intent to treat after liver transplantation (time frame: from day 1 of inclusion, up to 5 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2025.