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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 : September 11, 2020
Sponsor:
Collaborators:
French Eso-Gastric Tumors Working Group
National Cancer Institute, France
Information provided by (Responsible Party):
University Hospital, Lille

Tracking Information
First Submitted Date August 13, 2015
First Posted Date August 18, 2015
Last Update Posted Date September 11, 2020
Study Start Date June 2014
Estimated Primary Completion Date May 2027   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 14, 2015)		 DIsease free survival [ Time Frame: 5 year disease free survival ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: August 14, 2015)
  • overall survival [ Time Frame: 5 year overall survival ]
  • recurrence rate [ Time Frame: 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 ]
  • Total number of complications [ Time Frame: 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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The French EsoGastricTumours Data Base
Official Title National Oesophageal and Gastric Carcinomas Data Base Construction: the FREGAT (French EsoGastric Tumours) Data Base
Brief Summary This retrospective study aims at evaluating the outcomes of gastrointestinal stromal tumor after surgery.
Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 13 Years
Biospecimen Not Provided
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.
Condition Esophageal Disease
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Mariette C, Renaud F, Piessen G, Gele P, Copin MC, Leteurtre E, Delaeter C, Dib M, Clisant S, Harter V, Bonnetain F, Duhamel A, Christophe V, Adenis A; Fregat Working Group. The FREGAT biobank: a clinico-biological database dedicated to esophageal and gastric cancers. BMC Cancer. 2018 Feb 6;18(1):139. doi: 10.1186/s12885-018-3991-8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 14, 2015)		 15000
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 2027
Estimated Primary Completion Date May 2027   (Final data collection date for primary outcome measure)
Eligibility 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 .
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Guillaume Piessen, MD, PhD +3320444407 guillaume.piessen@chru-lille.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT02526095
Other Study ID Numbers 2013_33
2013-A01281-44 ( Other Identifier: ID RCB number, ANSM )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party University Hospital, Lille
Original Responsible Party Same as current
Current Study Sponsor University Hospital, Lille
Original Study Sponsor Same as current
Collaborators
  • French Eso-Gastric Tumors Working Group
  • National Cancer Institute, France
Investigators
Study Director: Guillaume Piessen, MD, PhD University Hospital, Lille
PRS Account University Hospital, Lille
Verification Date September 2020