Ignite Creation Date:
2025-12-24 @ 12:41 PM
Ignite Modification Date:
2026-01-19 @ 8:00 PM
Study NCT ID:
NCT02893761
Status:
RECRUITING
Last Update Posted:
2025-09-23
First Post:
2016-08-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bergonie Institute Breast Cancer Database
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '1990-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2050-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-22', 'studyFirstSubmitDate': '2016-08-18', 'studyFirstSubmitQcDate': '2016-09-02', 'lastUpdatePostDateStruct': {'date': '2025-09-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-09-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2030-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Distant metastasis-free survival at 5 years', 'timeFrame': '5 years'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['breast cancer', 'survival'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '30683448', 'type': 'BACKGROUND', 'citation': 'Lhenaff M, Tunon de Lara C, Fournier M, Charitansky H, Brouste V, Mathoulin-Pelissier S, Pinsolles V, Rousvoal A, Bussieres E, Chassaigne F, Croce S, Ben Rejeb H, MacGrogan G. A single-center study on total mastectomy versus skin-sparing mastectomy in case of pure ductal carcinoma in situ of the breast. Eur J Surg Oncol. 2019 Jun;45(6):950-955. doi: 10.1016/j.ejso.2019.01.014. Epub 2019 Jan 17.'}, {'pmid': '18820667', 'type': 'BACKGROUND', 'citation': 'de Mascarel I, MacGrogan G, Debled M, Sierankowski G, Brouste V, Mathoulin-Pelissier S, Mauriac L. D2-40 in breast cancer: should we detect more vascular emboli? Mod Pathol. 2009 Feb;22(2):216-22. doi: 10.1038/modpathol.2008.151. Epub 2008 Sep 26.'}, {'pmid': '26405647', 'type': 'BACKGROUND', 'citation': 'de Mascarel I, Debled M, Brouste V, Mauriac L, Sierankowski G, Velasco V, Croce S, Chibon F, Boudeau J, Debant A, MacGrogan G. Comprehensive prognostic analysis in breast cancer integrating clinical, tumoral, micro-environmental and immunohistochemical criteria. Springerplus. 2015 Sep 21;4:528. doi: 10.1186/s40064-015-1297-8. eCollection 2015.'}, {'pmid': '20564641', 'type': 'BACKGROUND', 'citation': 'Ragage F, Debled M, MacGrogan G, Brouste V, Desrousseaux M, Soubeyran I, de Lara CT, Mauriac L, de Mascarel I. Is it useful to detect lymphovascular invasion in lymph node-positive patients with primary operable breast cancer? Cancer. 2010 Jul 1;116(13):3093-101. doi: 10.1002/cncr.25137.'}, {'pmid': '28280221', 'type': 'BACKGROUND', 'citation': 'Morgat C, MacGrogan G, Brouste V, Velasco V, Sevenet N, Bonnefoi H, Fernandez P, Debled M, Hindie E. Expression of Gastrin-Releasing Peptide Receptor in Breast Cancer and Its Association with Pathologic, Biologic, and Clinical Parameters: A Study of 1,432 Primary Tumors. J Nucl Med. 2017 Sep;58(9):1401-1407. doi: 10.2967/jnumed.116.188011. Epub 2017 Mar 9.'}, {'pmid': '25944225', 'type': 'BACKGROUND', 'citation': 'Mazroui Y, Mauguen A, Mathoulin-Pelissier S, MacGrogan G, Brouste V, Rondeau V. Time-varying coefficients in a multivariate frailty model: Application to breast cancer recurrences of several types and death. Lifetime Data Anal. 2016 Apr;22(2):191-215. doi: 10.1007/s10985-015-9327-y. Epub 2015 May 6.'}, {'pmid': '24814311', 'type': 'BACKGROUND', 'citation': 'Debled M, Auxepaules G, de Lara CT, Garbay D, Brouste V, Bussieres E, Mauriac L, MacGrogan G. Neoadjuvant endocrine treatment in breast cancer: analysis of daily practice in large cancer center to facilitate decision making. Am J Surg. 2014 Nov;208(5):756-763. doi: 10.1016/j.amjsurg.2013.12.032. Epub 2014 Apr 3.'}, {'pmid': '35263698', 'type': 'BACKGROUND', 'citation': 'Jones N, Gros A, Velasco V, Dapremont V, Brouste V, Gastaldello B, Debled M, Tunon de Lara C, Bonnet F, Barouk-Simonet E, Bubien V, Venat L, MacGrogan G, Longy M, Sevenet N. PTEN alterations in sporadic and BRCA1-associated triple negative breast carcinomas. Cancer Genet. 2022 Jun;264-265:8-15. doi: 10.1016/j.cancergen.2022.02.008. Epub 2022 Feb 25.'}]}, 'descriptionModule': {'briefSummary': "A database of breast cancer patients was established at Institute Bergonié since the 90s , to assess patients' survival, assess practice, search for prognostic factors."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient with breast cancer treated at Bergonie Institute', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Breast cancer\n* Aged 18 years and over\n* First treatment at Bergonie Institute\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT02893761', 'briefTitle': 'Bergonie Institute Breast Cancer Database', 'organization': {'class': 'OTHER', 'fullName': 'Institut Bergonié'}, 'orgStudyIdInfo': {'id': 'IB BASE SEIN'}}, 'contactsLocationsModule': {'locations': [{'city': 'Bordeaux', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Institut Bergonié, Comprehensive Cancer Center', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}], 'centralContacts': [{'name': 'Gaetan Mac Grogan, MD', 'role': 'CONTACT', 'email': 'g.macgrogan@bordeaux.unicancer.fr', 'phone': '+ 33 5 56 33 33 33'}, {'name': 'Simone Mathoulin-Pélissier, MD PhD', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Gaetan Mac Grogan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut Bergonié'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Bergonié', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}