Recruiting NCT02526095
The French EsoGastricTumours Data Base
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Esophageal Disease. Basic parameters: 18 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
National Oesophageal and Gastric Carcinomas Data Base Construction: the FREGAT (French EsoGastric Tumours) Data Base
Overview
This retrospective study aims at evaluating the outcomes of gastrointestinal stromal tumor after surgery.
Primary outcome measures
- DIsease free survival [Time frame: 5 year disease free survival]
Secondary outcome measures (5)
- 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]
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 .
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 31 centers
- Chu Amiens Picardie — Amiens
- Chru Besancon — Besançon
- Hu Paris Site Avicenne Aphp — Bobigny
- Chu de Caen Normandie — Caen
- Crlcc Francois Baclesse — Caen
- Hopital Estaing - Chu63 - Clermont Ferrand — Clermont-Ferrand
- Hu Paris Nord Site Louis Mourier Aphp — Colombes
- Hopital Le Bocage Chru Dijon — Dijon
- … and 23 more centers
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. PMID 29409462
Identifiers
NCT: NCT02526095 · 2013_33 · 2013-A01281-44