Clinical trial NCT02526095: The French EsoGastricTumours Data Base
Official title: National Oesophageal and Gastric Carcinomas Data Base Construction: the FREGAT (French EsoGastric Tumours) Data Base
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Esophageal Disease
Keywords: Esophagus
Surgery
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: French Eso-Gastric Tumors Working Group
name: National Cancer Institute, France
First posted: 2015-08-18
Enrollment: 15000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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


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 .

Primary outcomes:
measure: DIsease free survival
timeFrame: 5 year disease free survival
Secondary outcomes:
measure: overall survival
timeFrame: 5 year overall survival
measure: recurrence rate
timeFrame: 5 year recurrence rate
measure: Total number of patients with complications
timeFrame: from the time between inclusion and occurrence of the event, for the duration of 3 years
measure: Total number of complications
timeFrame: from the time between inclusion and occurrence of the event, for the duration of 3 years
measure: Death
timeFrame: from the time between inclusion and occurrence of the event, for the duration of 3 years
Other outcomes:
Locations:
city: Amiens
country: France
facility: Chu Amiens Picardie
city: Besançon
country: France
facility: Chru Besancon
city: Bobigny
country: France
facility: Hu Paris Site Avicenne Aphp
city: Caen
country: France
facility: Chu de Caen Normandie
city: Caen
country: France
facility: Crlcc Francois Baclesse
city: Clermont-Ferrand
country: France
facility: Hopital Estaing - Chu63 - Clermont Ferrand
city: Colombes
country: France
facility: Hu Paris Nord Site Louis Mourier Aphp
city: Dijon
country: France
facility: Hopital Le Bocage Chru Dijon
city: Grenoble
country: France
facility: Chu de Grenoble Alpes
city: Lille
country: France
facility: Hop Claude Huriez Chu Lille
city: Lille
country: France
facility: Clcc Oscar Lambret Lille
city: Limoges
country: France
facility: C H U Dupuytren Limoges
city: Lyon
country: France
facility: Hospices Civils de Lyon (Pierre Bénite,Edouard Herriot, La Croix Rousse)
city: Marseille
country: France
facility: Aphm Hopital Nord
city: Montpellier
country: France
facility: Hopital St Eloi Chu Montpellier
city: Montpellier
country: France
facility: Icm - Montpellier
city: Nantes
country: France
facility: Chu de Nantes :Site Hôtel-Dieu- Hme
city: Nîmes
country: France
facility: Chu Nimes
city: Paris
country: France
facility: Hu Est Parisien Site St Antoine Aphp
city: Paris
country: France
facility: Hu Paris Centre Site Cochin Aphp
city: Paris
country: France
facility: Hu Paris Sud Site Kremlin Bicetre Aphp
city: Paris
country: France
facility: Hu Saint Louis Site Saint Louis Aphp
city: Pessac
country: France
facility: Hopital Haut-Leveque - Chu - Pessac
city: Reims
country: France
facility: Hopital Robert Debre Chu Reims
city: Rennes
country: France
facility: Chru Rennes Site Pontchaillou
city: Rouen
country: France
facility: Hopital Charles Nicolle Chu Rouen
city: Strasbourg
country: France
facility: Hus/Hop Hautepierre
city: Toulouse
country: France
facility: Hopital Purpan Chu
city: Tours
country: France
facility: Chu de Tours
city: Vandœuvre-lès-Nancy
country: France
facility: Institut de Cancerologie de Lorraine
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
affiliation: University Hospital, Lille
name: Guillaume Piessen, MD, PhD
role: STUDY_DIRECTOR
References:
citation: 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.