Trial record 1 of 1 for:
NCT02526095
The French EsoGastricTumours Data Base (FREGAT)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02526095 |
Recruitment Status :
Recruiting
First Posted : August 18, 2015
Last Update Posted : September 11, 2020
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Sponsor:
University Hospital, Lille
Collaborators:
French Eso-Gastric Tumors Working Group
National Cancer Institute, France
Information provided by (Responsible Party):
University Hospital, Lille
Tracking Information | |||||
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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 |
DIsease free survival [ Time Frame: 5 year disease free survival ] | ||||
Original Primary Outcome Measures | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures |
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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 |
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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. |
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Recruitment Information | |||||
Recruitment Status | Recruiting | ||||
Estimated Enrollment |
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
Exclusion Criteria: Male or female aged ( e) under 18 years.
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Sex/Gender |
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Ages | 18 Years to 90 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts |
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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 ) |
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Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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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 |
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Investigators |
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PRS Account | University Hospital, Lille | ||||
Verification Date | September 2020 |