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

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

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

Observational

Enrollment (Estimated)

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 Locations

      • 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

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

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

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.

Investigators

  • Principal Investigator: jean-charles nault, Pr, Federation Francophone de Cancerologie 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)

March 26, 2024

Primary Completion (Estimated)

February 1, 2026

Study Completion (Estimated)

February 1, 2031

Study Registration Dates

First Submitted

July 15, 2024

First Submitted That Met QC Criteria

August 2, 2024

First Posted (Actual)

August 7, 2024

Study Record Updates

Last Update Posted (Actual)

August 5, 2025

Last Update Submitted That Met QC Criteria

August 4, 2025

Last Verified

February 1, 2025

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

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.

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