The French EsoGastricTumours Data Base

Esophageal Disease Clinical Trial

— FREGAT  

Official title:

National Oesophageal and Gastric Carcinomas Data Base Construction: the FREGAT (French EsoGastric Tumours) Data Base

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02526095
• Other study ID #: 2013_33
• Secondary ID: 2013-A01281-44
• Status: Recruiting
• Start date: June 2014
• Est. completion date: May 2027

Study information

• Verified date: September 2020
• Source: University Hospital, Lille
• Contact: Guillaume Piessen, MD, PhD
• Phone: +3320444407
• Email: guillaume.piessen[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15000
• Est. completion date: May 2027
• Est. primary completion date: May 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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 .

Related Conditions & MeSH terms

• Esophageal Disease
• Esophageal Diseases

Locations

Country	Name	City	State
France	Chu Amiens Picardie	Amiens
France	Chru Besancon	Besançon
France	Hu Paris Site Avicenne Aphp	Bobigny
France	Chu de Caen Normandie	Caen
France	Crlcc Francois Baclesse	Caen
France	Hopital Estaing - Chu63 - Clermont Ferrand	Clermont-Ferrand
France	Hu Paris Nord Site Louis Mourier Aphp	Colombes
France	Hopital Le Bocage Chru Dijon	Dijon
France	Chu de Grenoble Alpes	Grenoble
France	Clcc Oscar Lambret Lille	Lille
France	Hop Claude Huriez Chu Lille	Lille
France	C H U Dupuytren Limoges	Limoges
France	Hospices Civils de Lyon (Pierre Bénite,Edouard Herriot, La Croix Rousse)	Lyon
France	Aphm Hopital Nord	Marseille
France	Hopital St Eloi Chu Montpellier	Montpellier
France	Icm - Montpellier	Montpellier
France	Chu de Nantes :Site Hôtel-Dieu- Hme	Nantes
France	Chu Nimes	Nîmes
France	Hu Est Parisien Site St Antoine Aphp	Paris
France	Hu Paris Centre Site Cochin Aphp	Paris
France	Hu Paris Sud Site Kremlin Bicetre Aphp	Paris
France	Hu Saint Louis Site Saint Louis Aphp	Paris
France	Hopital Haut-Leveque - Chu - Pessac	Pessac
France	Hopital Robert Debre Chu Reims	Reims
France	Chru Rennes Site Pontchaillou	Rennes
France	Hopital Charles Nicolle Chu Rouen	Rouen
France	Hus/Hop Hautepierre	Strasbourg
France	Hopital Purpan Chu	Toulouse
France	Chu de Tours	Tours
France	Institut de Cancerologie de Lorraine	Vandœuvre-lès-Nancy
France	Institut Gustave Roussy	Villejuif

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Lille	French Eso-Gastric Tumors Working Group, National Cancer Institute, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DIsease free survival		5 year disease free survival
Secondary	overall survival		5 year overall survival
Secondary	recurrence rate		5 year recurrence rate
Secondary	Total number of patients with complications		from the time between inclusion and occurrence of the event, for the duration of 3 years
Secondary	Total number of complications		from the time between inclusion and occurrence of the event, for the duration of 3 years
Secondary	Death		from the time between inclusion and occurrence of the event, for the duration of 3 years

External Links

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