NCT02526095

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15,000

participants targeted

Target at P75+ for all trials

Timeline
12mo left

Started Jun 2014

Longer than P75 for all trials

Geographic Reach
1 country

31 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress92%
Jun 2014May 2027

Study Start

First participant enrolled

June 1, 2014

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 13, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 18, 2015

Completed
11.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

September 11, 2020

Status Verified

September 1, 2020

Enrollment Period

12.9 years

First QC Date

August 13, 2015

Last Update Submit

September 10, 2020

Conditions

Keywords

EsophagusSurgery

Outcome Measures

Primary Outcomes (1)

  • DIsease free survival

    5 year disease free survival

Secondary Outcomes (5)

  • overall survival

    5 year overall survival

  • recurrence rate

    5 year recurrence rate

  • Total number of patients with complications

    from the time between inclusion and occurrence of the event, for the duration of 3 years

  • Total number of complications

    from the time between inclusion and occurrence of the event, for the duration of 3 years

  • Death

    from the time between inclusion and occurrence of the event, for the duration of 3 years

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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 .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (31)

Chu Amiens Picardie

Amiens, France

RECRUITING

Chru Besancon

Besançon, France

RECRUITING

Hu Paris Site Avicenne Aphp

Bobigny, France

RECRUITING

Chu de Caen Normandie

Caen, France

RECRUITING

Crlcc Francois Baclesse

Caen, France

RECRUITING

Hopital Estaing - Chu63 - Clermont Ferrand

Clermont-Ferrand, France

RECRUITING

Hu Paris Nord Site Louis Mourier Aphp

Colombes, France

RECRUITING

Hopital Le Bocage Chru Dijon

Dijon, France

RECRUITING

Chu de Grenoble Alpes

Grenoble, France

RECRUITING

Hop Claude Huriez Chu Lille

Lille, 59045, France

RECRUITING

Clcc Oscar Lambret Lille

Lille, France

RECRUITING

C H U Dupuytren Limoges

Limoges, France

RECRUITING

Hospices Civils de Lyon (Pierre Bénite,Edouard Herriot, La Croix Rousse)

Lyon, France

RECRUITING

Aphm Hopital Nord

Marseille, France

RECRUITING

Hopital St Eloi Chu Montpellier

Montpellier, France

RECRUITING

Icm - Montpellier

Montpellier, France

RECRUITING

Chu de Nantes :Site Hôtel-Dieu- Hme

Nantes, France

RECRUITING

Chu Nimes

Nîmes, France

RECRUITING

Hu Est Parisien Site St Antoine Aphp

Paris, France

RECRUITING

Hu Paris Centre Site Cochin Aphp

Paris, France

RECRUITING

Hu Paris Sud Site Kremlin Bicetre Aphp

Paris, France

RECRUITING

Hu Saint Louis Site Saint Louis Aphp

Paris, France

RECRUITING

Hopital Haut-Leveque - Chu - Pessac

Pessac, 33604, France

RECRUITING

Hopital Robert Debre Chu Reims

Reims, France

RECRUITING

Chru Rennes Site Pontchaillou

Rennes, France

RECRUITING

Hopital Charles Nicolle Chu Rouen

Rouen, France

RECRUITING

Hus/Hop Hautepierre

Strasbourg, France

RECRUITING

Hopital Purpan Chu

Toulouse, France

RECRUITING

Chu de Tours

Tours, France

RECRUITING

Institut de Cancerologie de Lorraine

Vandœuvre-lès-Nancy, France

RECRUITING

Institut Gustave Roussy

Villejuif, France

RECRUITING

Related Publications (1)

  • 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.

Related Links

MeSH Terms

Conditions

Esophageal Diseases

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Guillaume Piessen, MD, PhD

    University Hospital, Lille

    STUDY DIRECTOR

Central Study Contacts

Guillaume Piessen, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
13 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2015

First Posted

August 18, 2015

Study Start

June 1, 2014

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

September 11, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations