Esophageal DiseaseFREGATNCT02526095
The French EsoGastricTumours Data Base
An observational study of Esophageal Disease, run by University Hospital, Lille at 31 sites in France.
Trial summary
This retrospective study aims at evaluating the outcomes of gastrointestinal stromal tumor after surgery. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Esophageal Disease
- How many people
- 15,000 participants
- Where
- 31 sitesFrance
- Study dates
- Jun 2014to May 2027
- How long will I take part?
- 13 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older 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.
Who may be able to join
- 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.
Who cannot join
- 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 .
Trial locations and contacts
31 sites in 1 country. Contact the study team or a site near you to ask about taking part.
31 sites in 1 country
France31 sites, 31 recruiting
- Recruiting
Chu Amiens Picardie
Amiens
- Recruiting
Chru Besancon
Besançon
- Recruiting
Hu Paris Site Avicenne Aphp
Bobigny
- Recruiting
Chu de Caen Normandie
Caen
Gilles Lebreton, MD, PhD
- Recruiting
Crlcc Francois Baclesse
Caen
Marie-Pierre Galais, MD,PhD
- Recruiting
Hopital Estaing - Chu63 - Clermont Ferrand
Clermont-Ferrand
- Recruiting
Hu Paris Nord Site Louis Mourier Aphp
Colombes
- Recruiting
Hopital Le Bocage Chru Dijon
Dijon
- Recruiting
Chu de Grenoble Alpes
Grenoble
- Recruiting
Hop Claude Huriez Chu Lille
Lille, 59045
guillaume Piessen, MD, PhD
- Recruiting
Clcc Oscar Lambret Lille
Lille
Xavier Mirabelle, MD,PhD
- Recruiting
C H U Dupuytren Limoges
Limoges
Muriel Mathonnet, Md,PhD
- Recruiting
Hospices Civils de Lyon (Pierre Bénite,Edouard Herriot, La Croix Rousse)
Lyon
Olivier Glehen, MD
- Recruiting
Aphm Hopital Nord
Marseille
- Recruiting
Hopital St Eloi Chu Montpellier
Montpellier
- Recruiting
Icm - Montpellier
Montpellier
- Recruiting
Chu de Nantes :Site Hôtel-Dieu- Hme
Nantes
- Recruiting
Chu Nimes
Nîmes
- Recruiting
Hu Est Parisien Site St Antoine Aphp
Paris
- Recruiting
Hu Paris Centre Site Cochin Aphp
Paris
- Recruiting
Hu Paris Sud Site Kremlin Bicetre Aphp
Paris
- Recruiting
Hu Saint Louis Site Saint Louis Aphp
Paris
- Recruiting
Hopital Haut-Leveque - Chu - Pessac
Pessac, 33604
0556556565
- Recruiting
Hopital Robert Debre Chu Reims
Reims
- Recruiting
Chru Rennes Site Pontchaillou
Rennes
- Recruiting
Hopital Charles Nicolle Chu Rouen
Rouen
- Recruiting
Hus/Hop Hautepierre
Strasbourg
- Recruiting
Hopital Purpan Chu
Toulouse
- Recruiting
Chu de Tours
Tours
- Recruiting
Institut de Cancerologie de Lorraine
Vandœuvre-lès-Nancy
- Recruiting
Institut Gustave Roussy
Villejuif
About this study
Official title: National Oesophageal and Gastric Carcinomas Data Base Construction: the FREGAT (French EsoGastric Tumours) Data Base
This retrospective study aims at evaluating the outcomes of gastrointestinal stromal tumor after surgery.
- Conditions
- Esophageal Disease
- Keywords
- Esophagus, Surgery
- Medical subject headings
- Esophageal Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
DIsease free survival
Measured: 5 year disease free survival
Secondary outcomes (5)
overall survival
Measured: 5 year overall survival
recurrence rate
Measured: 5 year recurrence rate
Total number of patients with complications
Measured: from the time between inclusion and occurrence of the event, for the duration of 3 years
Total number of complications
Measured: from the time between inclusion and occurrence of the event, for the duration of 3 years
Death
Measured: from the time between inclusion and occurrence of the event, for the duration of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2015 (estimated)
- Study startJun 2014
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Esophageal DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15,000 participants (estimated)
- Target duration
- 13 Years
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- French Eso-Gastric Tumors Working Group, National Cancer Institute, France
- Responsible party
- Sponsor
- Investigators
- Guillaume Piessen, MD, PhD, Study director, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02526095
- Sponsor's protocol ID
- 2013_33
- Other IDs
- 2013-A01281-44
- Acronym
- FREGAT
- Status last verified
- Sep 2020
- First submitted
- 13 Aug 2015
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 29409462
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Oesophageal and Gastric Carcinomas Data Base Construction: the FREGAT (French EsoGastric Tumours) Data Base
- ClinicalTrials.gov ID
- NCT02526095
- Acronym / sponsor ID
- FREGAT / 2013_33
- Conditions
- Esophageal Disease
- Keywords
- Esophagus, Surgery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 15,000 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- French Eso-Gastric Tumors Working Group, National Cancer Institute, France
- Study start
- Jun 2014
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 18 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This retrospective study aims at evaluating the outcomes of gastrointestinal stromal tumor after surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 13 Years
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (6 listed)
- 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 .
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
DIsease free survival
Time frame: 5 year disease free survival
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Background: PubMed 29409462Mariette 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 InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Esophageal Disease
RecruitingPhase 1/2
A Study of Bispecific Antibody MCLA-158 in Patients With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Colorectal Cancer
Recruiting
The Effectiveness of Structured Swallowing Exercise Therapy in Patients With Nasopharyngeal Carcinoma: An Assessment of Swallowing Function and Quality of Life
Nasopharyngeal Carcinoma (NPC)
Active, not recruiting
Clinical Application of an AI-based Dissection Trajectory Prediction System (ADTPS) in Endoscopic Submucosal Dissection
Esophageal Squamous Cell Carcinoma (ESCC), High-Grade Intraepithelial Neoplasia
RecruitingPhase 1/2
CR-002 in Adult Participants With Locally Advanced or Metastatic Solid Tumors
Head and Neck Squamous Cell Carcinoma (HNSCC) - Recurrent/Metastatic (R/M), Gastric/GEJ
RecruitingPhase 4
Intraoperative Imaging of Gastrointestinal Malignancies Using Pafolacianine (CYTALUX™)
Gastrointestinal Cancer, Gastric Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Guillaume Piessen, MD, PhD study director
University Hospital, Lille
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Disease, run by University Hospital, Lille at 31 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guillaume Piessen, MD, PhD (+3320444407, guillaume.piessen@chru-lille.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DIsease free survival (time frame: 5 year disease free survival). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02526095, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026; AzTrials last refreshed its copy on 3 Nov 2026.