Ignite Creation Date:
2025-12-24 @ 2:09 PM
Ignite Modification Date:
2026-02-17 @ 5:54 PM
Study NCT ID:
NCT02526095
Status:
RECRUITING
Last Update Posted:
2020-09-11
First Post:
2015-08-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The French EsoGastricTumours Data Base
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004935', 'term': 'Esophageal Diseases'}], 'ancestors': [{'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15000}, 'targetDuration': '13 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2027-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-09-10', 'studyFirstSubmitDate': '2015-08-13', 'studyFirstSubmitQcDate': '2015-08-14', 'lastUpdatePostDateStruct': {'date': '2020-09-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-08-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'DIsease free survival', 'timeFrame': '5 year disease free survival'}], 'secondaryOutcomes': [{'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'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Esophagus', 'Surgery'], 'conditions': ['Esophageal Disease']}, 'referencesModule': {'references': [{'pmid': '29409462', 'type': 'DERIVED', '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.'}], 'seeAlsoLinks': [{'url': 'https://www.fregat-database.org/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This retrospective study aims at evaluating the outcomes of gastrointestinal stromal tumor after surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: Patient with\n\n* esophageal cancer, gastric or gastroesophageal junction diagnosed biopsy , regardless of the subtype of cancer, tumor stage or treatment envisaged.\n* Naive treatment for this cancer,\n* Naive treatment for this cancer , failing that received neoadjuvant treatment ,\n* Male or female ≥ 18 years.\n* social protection scheme .\n* sign a free and informed consent for blood sampling , the different questionnaires and the collection of patient information.\n\nExclusion Criteria:\n\nMale or female aged ( e) under 18 years.\n\n* Private person of liberty or under supervision (including guardianship ) .\n* People who do not speak French.\n* Major Nobody unable to consent .\n* Patient FREGAT already included in the base.\n* Patient Refusal .'}, 'identificationModule': {'nctId': 'NCT02526095', 'acronym': 'FREGAT', 'briefTitle': 'The French EsoGastricTumours Data Base', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Lille'}, 'officialTitle': 'National Oesophageal and Gastric Carcinomas Data Base Construction: the FREGAT (French EsoGastric Tumours) Data Base', 'orgStudyIdInfo': {'id': '2013_33'}, 'secondaryIdInfos': [{'id': '2013-A01281-44', 'type': 'OTHER', 'domain': 'ID RCB number, ANSM'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Amiens', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Chu Amiens Picardie', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'city': 'Besançon', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Chru Besancon', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'city': 'Bobigny', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Hu Paris Site Avicenne Aphp', 'geoPoint': {'lat': 48.90982, 'lon': 2.45012}}, {'city': 'Caen', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Gilles Lebreton, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Chu de Caen Normandie', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'city': 'Caen', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Marie-Pierre Galais, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Crlcc Francois Baclesse', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'city': 'Clermont-Ferrand', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Hopital Estaing - Chu63 - Clermont Ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'city': 'Colombes', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Hu Paris Nord Site Louis Mourier Aphp', 'geoPoint': {'lat': 48.91882, 'lon': 2.25404}}, {'city': 'Dijon', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Hopital Le Bocage Chru Dijon', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'city': 'Grenoble', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Chu de Grenoble Alpes', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '59045', 'city': 'Lille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'guillaume Piessen, MD, PhD', 'role': 'CONTACT'}], 'facility': 'Hop Claude Huriez Chu Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Lille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Xavier Mirabelle, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Clcc Oscar Lambret Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Limoges', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Muriel Mathonnet, Md,PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'C H U Dupuytren Limoges', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Olivier Glehen, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospices Civils de Lyon (Pierre Bénite,Edouard Herriot, La Croix Rousse)', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Marseille', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Aphm Hopital Nord', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Montpellier', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Hopital St Eloi Chu Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'city': 'Montpellier', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Icm - Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'city': 'Nantes', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Chu de Nantes :Site Hôtel-Dieu- Hme', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'city': 'Nîmes', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Chu Nimes', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Hu Est Parisien Site St Antoine Aphp', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Hu Paris Centre Site Cochin Aphp', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Hu Paris Sud Site Kremlin Bicetre Aphp', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Hu Saint Louis Site Saint Louis Aphp', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '33604', 'city': 'Pessac', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'role': 'CONTACT', 'phone': '0556556565'}], 'facility': 'Hopital Haut-Leveque - Chu - Pessac', 'geoPoint': {'lat': 44.80565, 'lon': -0.6324}}, {'city': 'Reims', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Hopital Robert Debre Chu Reims', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}, {'city': 'Rennes', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Chru Rennes Site Pontchaillou', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'city': 'Rouen', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Hopital Charles Nicolle Chu Rouen', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'city': 'Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Hus/Hop Hautepierre', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'city': 'Toulouse', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Hopital Purpan Chu', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'city': 'Tours', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Chu de Tours', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}, {'city': 'Vandœuvre-lès-Nancy', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Institut de Cancerologie de Lorraine', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}, {'city': 'Villejuif', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Institut Gustave Roussy', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}], 'centralContacts': [{'name': 'Guillaume Piessen, MD, PhD', 'role': 'CONTACT', 'email': 'guillaume.piessen@chru-lille.fr', 'phone': '+3320444407'}], 'overallOfficials': [{'name': 'Guillaume Piessen, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Hospital, Lille'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Lille', 'class': 'OTHER'}, 'collaborators': [{'name': 'French Eso-Gastric Tumors Working Group', 'class': 'OTHER'}, {'name': 'National Cancer Institute, France', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}