The French EsoGastricTumours Data Base (FREGAT)
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| ClinicalTrials.gov Identifier: NCT02526095 |
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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
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Brief Summary:
This retrospective study aims at evaluating the outcomes of gastrointestinal stromal tumor after surgery.
| Condition or disease |
|---|
| Esophageal Disease |
| 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 :
- DIsease free survival [ Time Frame: 5 year disease free survival ]
Secondary Outcome Measures :
- 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 ]
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
| Contact: Guillaume Piessen, MD, PhD | +3320444407 | guillaume.piessen@chru-lille.fr |
Locations
Show 31 study locations
Sponsors and Collaborators
University Hospital, Lille
French Eso-Gastric Tumors Working Group
National Cancer Institute, France
Investigators
| Study Director: | Guillaume Piessen, MD, PhD | University Hospital, Lille |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | University Hospital, Lille |
| ClinicalTrials.gov Identifier: | NCT02526095 |
| 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: | September 11, 2020 |
| Last Verified: | September 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by University Hospital, Lille:
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Esophagus Surgery |
Additional relevant MeSH terms:
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Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases |