The French EsoGastricTumours Data Base | NCT02526095

Studies
The French EsoGastricTumours Data Base

NCT02526095

Sponsor

University Hospital, Lille

Status

Recruiting

Last Update Posted

May 14, 2026Actual

Enrollment

15,000Estimated

Phase

Not provided

Conditions

Esophageal Disease

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2013-A01281-44	Other Identifier	ID RCB number, ANSM

Status Module

Record Verification Date

Sep 2020

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2014

Primary Completion Date

May 2027Estimated

Completion Date

May 2027Estimated

First Submitted Date

Aug 13, 2015

First Submission Date that Met QC Criteria

Aug 14, 2015

First Posted Date

Aug 18, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 11, 2026

Last Update Posted Date

May 14, 2026Actual

Name	Class
French Eso-Gastric Tumors Working Group	OTHER
National Cancer Institute, France	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

13 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

15,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
DIsease free survival		5 year disease free survival

Secondary Outcomes

Measure	Description	Time Frame
overall survival		5 year overall survival
recurrence rate		5 year recurrence rate
Total number of patients with complications

Other Outcomes

Not provided

Eligibility Module

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 .

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Guillaume Piessen, MD, PhD	Contact	+3320444407		guillaume.piessen@chru-lille.fr

Overall Officials

Name	Affiliation	Role
Guillaume Piessen, MD, PhD	University Hospital, Lille	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chu Amiens Picardie	Recruiting	Amiens			France
Chru Besancon

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29409462	Background	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.

ID	Term
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases