The French EsoGastricTumours Data Base (FREGAT)

September 10, 2020 updated by: University Hospital, Lille

National Oesophageal and Gastric Carcinomas Data Base Construction: the FREGAT (French EsoGastric Tumours) Data Base

This retrospective study aims at evaluating the outcomes of gastrointestinal stromal tumor after surgery.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

15000

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

  • France
      • Amiens, France
        • Recruiting
        • CHU Amiens Picardie
      • Besançon, France
        • Recruiting
        • CHRU Besancon
      • Bobigny, France
        • Recruiting
        • Hu Paris Site Avicenne Aphp
      • Caen, France
        • Recruiting
        • CHU de Caen Normandie
        • Principal Investigator:
          • Gilles Lebreton, MD, PhD
      • Caen, France
        • Recruiting
        • Crlcc Francois Baclesse
        • Principal Investigator:
          • Marie-Pierre Galais, MD,PhD
      • Clermont-Ferrand, France
        • Recruiting
        • Hopital Estaing - Chu63 - Clermont Ferrand
      • Colombes, France
        • Recruiting
        • Hu Paris Nord Site Louis Mourier Aphp
      • Dijon, France
        • Recruiting
        • Hopital Le Bocage Chru Dijon
      • Grenoble, France
        • Recruiting
        • CHU de Grenoble Alpes
      • Lille, France, 59045
        • Recruiting
        • Hop Claude Huriez Chu Lille
        • Contact:
          • guillaume Piessen, MD, PhD
      • Lille, France
        • Recruiting
        • Clcc Oscar Lambret Lille
        • Principal Investigator:
          • Xavier Mirabelle, MD,PhD
      • Limoges, France
        • Recruiting
        • C H U Dupuytren Limoges
        • Principal Investigator:
          • Muriel Mathonnet, Md,PhD
      • Lyon, France
        • Recruiting
        • Hospices Civils de Lyon (Pierre Bénite,Edouard Herriot, La Croix Rousse)
      • Marseille, France
        • Recruiting
        • APHM Hopital Nord
      • Montpellier, France
        • Recruiting
        • Hopital St Eloi Chu Montpellier
      • Montpellier, France
        • Recruiting
        • ICM - Montpellier
      • Nantes, France
        • Recruiting
        • Chu de Nantes :Site Hôtel-Dieu- Hme
      • Nîmes, France
        • Recruiting
        • CHU Nîmes
      • Paris, France
        • Recruiting
        • Hu Est Parisien Site St Antoine Aphp
      • Paris, France
        • Recruiting
        • Hu Paris Centre Site Cochin Aphp
      • Paris, France
        • Recruiting
        • Hu Paris Sud Site Kremlin Bicetre Aphp
      • Paris, France
        • Recruiting
        • Hu Saint Louis Site Saint Louis Aphp
      • Pessac, France, 33604
        • Recruiting
        • Hopital Haut-Leveque - Chu - Pessac
        • Contact:
          • Phone Number: 0556556565
      • Reims, France
        • Recruiting
        • Hopital Robert Debre Chu Reims
      • Rennes, France
        • Recruiting
        • Chru Rennes Site Pontchaillou
      • Rouen, France
        • Recruiting
        • Hopital Charles Nicolle Chu Rouen
      • Strasbourg, France
        • Recruiting
        • Hus/Hop Hautepierre
      • Toulouse, France
        • Recruiting
        • Hopital Purpan Chu
      • Tours, France
        • Recruiting
        • CHU de Tours
      • Vandœuvre-lès-Nancy, France
        • Recruiting
        • Institut de Cancerologie de Lorraine
      • Villejuif, France
        • Recruiting
        • Institut Gustave Roussy

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 to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All patients with gastroesophageal cancer diagnosed and treatment-naïve, if not receiving neoadjuvant treatment in a participating center will be included after acceptance and signature of consent, whether operated or not, whatever histologic type, tumor stage, and the therapeutic strategy.

Description

Inclusion Criteria: Patient with

  • esophageal cancer, gastric or gastroesophageal junction diagnosed biopsy , regardless of the subtype of cancer, tumor stage or treatment envisaged.
  • Naive treatment for this cancer,
  • Naive treatment for this cancer , failing that received neoadjuvant treatment ,
  • Male or female ≥ 18 years.
  • social protection scheme .
  • sign a free and informed consent for blood sampling , the different questionnaires and the collection of patient information.

Exclusion Criteria:

Male or female aged ( e) under 18 years.

  • Private person of liberty or under supervision (including guardianship ) .
  • People who do not speak French.
  • Major Nobody unable to consent .
  • Patient FREGAT already included in the base.
  • Patient Refusal .

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
Time Frame
DIsease free survival
Time Frame: 5 year disease free survival
5 year disease free survival

Secondary Outcome Measures

Outcome Measure
Time Frame
overall survival
Time Frame: 5 year overall survival
5 year overall survival
recurrence rate
Time Frame: 5 year recurrence rate
5 year recurrence rate
Total number of patients with complications
Time Frame: from the time between inclusion and occurrence of the event, for the duration of 3 years
from the time between inclusion and occurrence of the event, for the duration of 3 years
Total number of complications
Time Frame: from the time between inclusion and occurrence of the event, for the duration of 3 years
from the time between inclusion and occurrence of the event, for the duration of 3 years
Death
Time Frame: from the time between inclusion and occurrence of the event, for the duration of 3 years
from the time between inclusion and occurrence of the event, for the duration of 3 years

Collaborators and Investigators

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

Sponsor

University Hospital, Lille

Collaborators

National Cancer Institute, France
French Eso-Gastric Tumors Working Group

Investigators

  • Study Director: Guillaume Piessen, MD, PhD, University Hospital, Lille

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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

June 1, 2014

Primary Completion (Anticipated)

May 1, 2027

Study Completion (Anticipated)

May 1, 2027

Study Registration Dates

First Submitted

August 13, 2015

First Submitted That Met QC Criteria

August 14, 2015

First Posted (Estimate)

August 18, 2015

Study Record Updates

Last Update Posted (Actual)

September 11, 2020

Last Update Submitted That Met QC Criteria

September 10, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013_33
  • 2013-A01281-44 (Other Identifier: ID RCB number, 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

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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