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The French EsoGastricTumours Data Base (FREGAT)

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ClinicalTrials.gov Identifier: NCT02526095
Recruitment Status : Recruiting
First Posted : August 18, 2015
Last Update Posted : July 10, 2019
Sponsor:
Collaborators:
French Eso-Gastric Tumors Working Group
National Cancer Institute, France
Information provided by (Responsible Party):
University Hospital, Lille

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

Condition or disease
Esophageal Disease

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 15000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 13 Years
Official Title: National Oesophageal and Gastric Carcinomas Data Base Construction: the FREGAT (French EsoGastric Tumours) Data Base
Study Start Date : June 2014
Estimated Primary Completion Date : May 2027
Estimated Study Completion Date : May 2027

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. DIsease free survival [ Time Frame: 5 year disease free survival ]

Secondary Outcome Measures :
  1. overall survival [ Time Frame: 5 year overall survival ]
  2. recurrence rate [ Time Frame: 5 year recurrence rate ]
  3. Total number of patients with complications [ Time Frame: from the time between inclusion and occurrence of the event, for the duration of 3 years ]
  4. Total number of complications [ Time Frame: from the time between inclusion and occurrence of the event, for the duration of 3 years ]
  5. Death [ Time Frame: from the time between inclusion and occurrence of the event, for the duration of 3 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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 .

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02526095


Contacts
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Contact: Guillaume Piessen, MD, PhD +3320444407 guillaume.piessen@chru-lille.fr

Locations
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France
Centre François Baclesse Recruiting
Caen, France
Principal Investigator: Marie-Pierre Galais, MD,PhD         
Centre Hospitalier Universitaire Recruiting
Caen, France
Principal Investigator: Gilles Lebreton, MD, PhD         
University Hospital, Lille Recruiting
Lille, France, 59045
Contact: guillaume Piessen, MD, PhD         
Centre Oscar Lambret Recruiting
Lille, France
Principal Investigator: Xavier Mirabelle, MD,PhD         
Centre Hospitalier Universitaire Recruiting
Limoges, France
Principal Investigator: Muriel Mathonnet, Md,PhD         
Hospices Civils de Lyon (Pierre Bénite,Edouard Herriot, La Croix Rousse) Recruiting
Lyon, France
Principal Investigator: Olivier Glehen, MD         
Sponsors and Collaborators
University Hospital, Lille
French Eso-Gastric Tumors Working Group
National Cancer Institute, France
Investigators
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Study Director: Guillaume Piessen, MD, PhD University Hospital, Lille

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT02526095     History of Changes
Other Study ID Numbers: 2013_33
2013-A01281-44 ( Other Identifier: ID RCB number, ANSM )
First Posted: August 18, 2015    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Lille:
Esophagus
Surgery
Additional relevant MeSH terms:
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Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases