A French Multicenter Observational Retrospective Study of Rare Primary Liver Cancers (FFCD-2205)

August 4, 2025 updated by: Federation Francophone de Cancerologie Digestive
The aim of this French multicenter retrospective study is to describ rare primary hepatic cancers clinical, histological and radiological features, to obtain a biological tumor and blood collection, and to evaluate the efficacy of treatments received in clinical practice in order to determine optimal therapeutic sequences. This retrospective cohort will be the backbone of future translational studies aimed at identifying new molecular, histological, circulating and radiological tumor biomarkers, potentially useful at every stage of diagnosis and prognostic or theranostic evaluation.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

The aim is to describ rare primary hepatic cancers clinical, histological and radiological features, to obtain a biological tumor and blood collection, and to evaluate the efficacy of treatments received in clinical practice in order to determine optimal therapeutic sequences.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Amiens, France, 80054
      • Angers, France, 49933
        • Recruiting
        • CHU Angers
        • Contact:
      • Beauvais, France, 60021
        • Recruiting
        • Ch - Centresimone Veil de Beauvais
        • Contact:
      • Besançon, France
      • Bethune, France, 62408
        • Not yet recruiting
        • Ch Bethune Beuvry
        • Contact:
      • Bobigny, France, 93000
        • Recruiting
        • Avicenne
        • Contact:
      • Caen, France
      • Calais, France
        • Recruiting
        • Centre Hospitalier
        • Contact:
      • Clichy, France, 92110
        • Recruiting
        • Chu de Clichy Hopital Beaujon
        • Contact:
      • Creteil, France, 94010
        • Recruiting
        • Centre Hospitalier Universitaire Henri Mondor
        • Contact:
      • Dijon, France, 21079
      • La Tronche, France, 38700
        • Recruiting
        • CHU Grenobles Alpes
        • Contact:
      • Lille, France, 59000
      • Longjumeau, France
      • Lyon, France, 69008
      • Lyon, France, 69009
      • Lyon, France, 69002
      • Lyon, France
      • Lyon, France
      • Lyon, France
      • Marseille, France, 13385
        • Recruiting
        • CHU de la Timone
        • Contact:
      • Marseille, France, 13285
      • Metz, France, 57085
      • Orléans, France
      • Paris, France, 75571
        • Recruiting
        • Chu de Paris Saint Antoine
        • Contact:
      • Paris, France, 75651
        • Recruiting
        • AP - HP - Pitié Salpêtrière
        • Contact:
      • Pau, France, 64000
      • Perpignan, France, 66046
        • Recruiting
        • Centre Hospitalier de Perpignan
        • Contact:
      • Pessac, France, 33604
      • Poitiers, France, 86021
      • Pringy, France, 74374
      • Reims, France, 51000
        • Recruiting
        • CHU Robert Debré
        • Contact:
      • Rennes, France, 35042
      • Saint-Herblain, France, 44805
      • Saint-Malo, France, 35403
        • Recruiting
        • Groupe Hospitalier Rance Emeraude
        • Contact:
      • Saint-Priest-en-Jarez, France
      • Toulouse, France
      • Tours, France, 37044
        • Not yet recruiting
        • CHRU de Tours
        • Contact:
      • Villejuif, France
      • Villejuif, France

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

In the health centers, patients were identified in two ways:

  1. via diagnoses obtained in the anatomopathology departments of each investigating center
  2. via multidisciplinary consultation meetings on primary hepatic tumours/digestive oncology at each investigating center.

Patients with a diagnosis of rare primary hepatic cancers diagnosed on or after 01/01/2018 may be included, whether alive or deceased at the time of registration in the CAPRIH cohort.

Description

Inclusion Criteria:

  • 18 years of age or older,
  • with histologically proven hepato-cholangiocarcinoma, fibrolamellar hepatocellular carcinoma, epithelioid hemangioendothelioma or hepatic angiosarcoma
  • diagnosed after January 01, 2018 living or deceased at the time of registration in the cohort
  • for living patients who have not objected to the research: (note of non-objection to be attached° agreeing to participate in ancillary studies must sign the biological consent form for participation in biological studies.

Exclusion Criteria:

  • without social security
  • No access to tumor block

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Description of the clinical, histological and radiological characteristics of various rare primary liver cancers
Time Frame: up to 5 years from the date of diagnosis
Description of the clinical, histological and radiological characteristics of various rare primary liver cancers
up to 5 years from the date of diagnosis

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Recurrence-free survival (for non-metastatic patients)
Time Frame: up to 5 years from diagnosis
Time interval between the date of disease diagnosis and the date of locoregional and/or metastatic recurrence or death (all causes). Patients alive and without recurrence will be censored at the date of last news
up to 5 years from diagnosis
Progression-free survival (for metastatic patients)
Time Frame: up to 5 years from diagnosis
Time interval between the date of diagnosis of the disease and the date of radiological and/or clinical progression or death (all causes). Patients alive and progression-free will be censored at the date of last news.
up to 5 years from diagnosis
Overall survival
Time Frame: up to 5 years from diagnosis
Time interval between the date of diagnosis of the disease and the date of death (from all causes). Living patients will be censored at the date of last news.
up to 5 years from diagnosis

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Federation Francophone de Cancerologie Digestive

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Société Nationale Française de Gastroentérologie

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: jean-charles nault, Pr, Fédération Francophone de Cancérologie Digestive

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 26, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 15, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 2, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 7, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 5, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CAPRIH COHORT
  • 2023-A01517-38 (Registry Identifier: ID RCB ANSM)

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

product manufactured in and exported from the U.S.

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings