Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-25 @ 9:30 PM
Study NCT ID:
NCT07253051
Status:
RECRUITING
Last Update Posted:
2025-11-28
First Post:
2025-11-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
BRCA Mutation Carriers' Platform a Multicenter Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2045-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-19', 'studyFirstSubmitDate': '2025-11-19', 'studyFirstSubmitQcDate': '2025-11-19', 'lastUpdatePostDateStruct': {'date': '2025-11-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2045-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Collection data about BRCA mutation', 'timeFrame': '1 day', 'description': 'To collect data of each female individual carrying a BRCA1 or BRCA2 mutation'}], 'secondaryOutcomes': [{'measure': 'GEOGRAPHICAL DISTRIBUTION OF BRCA MUTATIONS', 'timeFrame': '6 months', 'description': 'GEOGRAPHICAL DISTRIBUTION OF BRCA MUTATIONS FOR IDENTIFY THE AREAS WHERE THE INCIDENCE OF THE MUTATION IS HIGHER THAN EXPECTED'}, {'measure': 'CENTRALIZATION OF CASES IN HIGHLY SPECIALIZED CENTERS', 'timeFrame': '6 months', 'description': 'CENTRALIZATION OF CASES IN HIGHLY SPECIALIZED CENTERS FOR THE PREVENTION AND TREATMENT OF GENETIC-RELATED CANCER'}, {'measure': 'RELATIONSHIP BETWEEN SPECIFIC MUTATIONS AND SPECIFIC TYPES OF CANCER', 'timeFrame': '6 months', 'description': 'DEFINITION OF THE RELATIONSHIP BETWEEN SPECIFIC MUTATIONS AND THE ONSET OF SPECIFIC TYPES OF CANCER'}, {'measure': 'CRITERIA FOR DETERMINING THE ACCESS TO GENETIC EVALUATION', 'timeFrame': '6 months', 'description': 'EVALUATION OF THE ADEQUACY OF THE CRITERIA FOR DETERMINING THE ACCESS TO GENETIC EVALUATION'}, {'measure': 'LIFESTYLE RISK FACTORS', 'timeFrame': '6 months', 'description': 'DEFINITION OF LIFESTYLE RISK FACTORS FOR THE DEVELOPMENT OF TUMORS IN BRCA MUTATION CARRIERS'}, {'measure': 'DEFINITION OF PREVENTIVE STRATEGIES', 'timeFrame': '6 months', 'description': 'HEALTHY SUBJECTS: DEFINITION OF RISK REDUCING OR PREVENTIVE STRATEGIES'}, {'measure': 'Risk-reducing salpingo-oophorectomy', 'timeFrame': '6 months', 'description': 'MANAGEMENT OF WOMEN AFTER RRSO (risk-reducing salpingo-oophorectomy) AFTER SURGERY'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['BRCA1 Mutation', 'BRCA2 Mutation']}, 'descriptionModule': {'briefSummary': 'Subjects who carry mutations in breast cancer susceptibility genes 1 and 2 (BRCA1 and BRCA2 genes) are at higher risk of developing cancers. Despite the cumulative amount of evidence published in the literature in the last two decades, the management of BRCA mutation carriers is still not completely defined.\n\nSince the prevalence of the mutation is estimated to be 1:400 - 1:500 individuals, the total number of BRCA mutation carriers should be around 140.000 - 150.000 in the Italian population. It is estimated that 87% of women with BRCA mutations will experience, in their lifetime, a tumor with a genetic origin. About 20% of the 5200 ovarian cancer cases diagnosed each year in Italy has a genetic origin and could potentially be the object of primary prevention. To date, and to the best of our knowledge, a national prospective data collection on women with BRCA mutations has not been yet established.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All women who are 18 years of age or older and known to be carriers of a pathogenetic mutation class 4 and 5 of the International Agency of Research on Cancer classification) of the BRCA1 or BRCA2 genes, who signed Informed Consent.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All women who are 18 years of age or older;\n* All women who known to be carriers of a pathogenetic mutation class 4 and 5 of the International Agency of Research on Cancer classification) of the BRCA1 or BRCA2 genes.\n\nExclusion Criteria:\n\n* Age \\< 18 years old;\n* No pathogenetic mutation carriers.'}, 'identificationModule': {'nctId': 'NCT07253051', 'acronym': 'BRCA_ENDORSE', 'briefTitle': "BRCA Mutation Carriers' Platform a Multicenter Study", 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}, 'officialTitle': "BRCA Mutation Carriers' Platform, a Multicenter Study", 'orgStudyIdInfo': {'id': '4224'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Registration of clinical datas in the platform', 'type': 'OTHER', 'description': 'Registration of clinical datas in the platform of female individual carrying a BRCA1 or BRCA2 mutation'}]}, 'contactsLocationsModule': {'locations': [{'zip': '83100', 'city': 'Avellino', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Francesca Falcone', 'role': 'CONTACT', 'email': 'francescafalcone@malzoni.org'}, {'name': 'Francesca Falcone', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Malzoni Research Hospital', 'geoPoint': {'lat': 40.91494, 'lon': 14.79103}}, {'zip': '33081', 'city': 'Aviano', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Antonino Ditto', 'role': 'CONTACT', 'email': 'antonino.ditto@cro.it'}, {'name': 'Antonino Ditto', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centro di Riferimento Oncologico IRCCS', 'geoPoint': {'lat': 46.07056, 'lon': 12.59472}}, {'zip': '70121', 'city': 'Bari', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Marco Marinaccio', 'role': 'CONTACT', 'email': 'marinacciom@yahoo.it'}, {'name': 'Marco Marinaccio', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Università degli Studi di Bari "Aldo Moro"', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}, {'zip': '70124', 'city': 'Bari', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Vera Loizzi', 'role': 'CONTACT', 'email': 'vera.loizzi@uniba.it'}, {'name': 'Vera Loizzi', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'IRCCS Istituto Tumori "Giovanni Paolo II"', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}, {'zip': '24127', 'city': 'Bergamo', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Valentina Ceni', 'role': 'CONTACT', 'email': 'valentina.ceni01@gmail.com'}, {'name': 'Valentina Ceni', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'ASST Papa Giovanni XXIII', 'geoPoint': {'lat': 45.69601, 'lon': 9.66721}}, {'zip': '95126', 'city': 'Catania', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Paolo Scollo', 'role': 'CONTACT', 'email': 'paolo.scollo@unikore.it'}, {'name': 'Paolo Scollo', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'L\'Azienda ospedaliera per l\'emergenza "Cannizzaro"', 'geoPoint': {'lat': 37.49223, 'lon': 15.07041}}, {'zip': '12100', 'city': 'Cuneo', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Marinella Destefanis', 'role': 'CONTACT', 'email': 'destefanis.m@ospedale.cuneo.it'}, {'name': 'Marinella Destefanis', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Azienda Ospedaliero Santa Croce e Carle', 'geoPoint': {'lat': 44.39071, 'lon': 7.54828}}, {'zip': '94100', 'city': 'Enna', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Daniela Sambataro', 'role': 'CONTACT', 'email': 'daniela.sambataro@unikore.it'}, {'name': 'Daniela Sambataro', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Presidio Ospedaliero Umberto I - ASP di Enna', 'geoPoint': {'lat': 37.5655, 'lon': 14.27433}}, {'zip': '50134', 'city': 'Florence', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Maria Cristina Petrella', 'role': 'CONTACT', 'email': 'mariacristina.petrella@gmail.com'}, {'name': 'Maria Cristina Petrella', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Azienda Ospedaliero Universitaria Careggi, Oncologia Medica Ginecologica', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'zip': '16132', 'city': 'Genova', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Lucia Trevisan', 'role': 'CONTACT', 'email': 'lucia.trevisan@hsanmartino.it', 'phone': '+393406098797'}, {'name': 'Lucia Trevisan', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'IRCCS Ospedale Policlinico San Martino', 'geoPoint': {'lat': 45.21604, 'lon': 11.87211}}, {'zip': '04100', 'city': 'Latina', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Teresa Di Palma', 'role': 'CONTACT', 'email': 't.dipalma@ausl.latina.it'}, {'name': 'Teresa Di Palma', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ospedale S. Maria Goretti, Latina', 'geoPoint': {'lat': 41.46614, 'lon': 12.9043}}, {'zip': '16033', 'city': 'Lavagna', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Stefano Bogliolo', 'role': 'CONTACT', 'email': 'dr.bogliolo@gmail.com'}, {'name': 'Stefano Bogliolo', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ospedale del Tigullio Polo di Lavagna - ASL 4 Chiavarese', 'geoPoint': {'lat': 44.3062, 'lon': 9.35383}}, {'zip': '73100', 'city': 'Lecce', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Elisabetta De Matteis', 'role': 'CONTACT', 'email': 'dr.dematteis.elisabetta@gmail.com'}, {'name': 'Elisabetta De Matteis', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ospedale Vito Fazzi, Lecce', 'geoPoint': {'lat': 40.35481, 'lon': 18.17244}}, {'zip': '47014', 'city': 'Meldola', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Valentina Arcangeli', 'role': 'CONTACT', 'email': 'valentina.arcangeli@auslromagna.it'}, {'name': 'Valentina Arcangeli', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori"', 'geoPoint': {'lat': 44.12775, 'lon': 12.0626}}, {'zip': '20132', 'city': 'Milan', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Emanuela Rabaiotti', 'role': 'CONTACT', 'email': 'rabaiotti.emanuela@hsr.it'}, {'name': 'Emanuela Rabaiotti', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'IRCCS Ospedale San Raffaele', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '20133', 'city': 'Milan', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giovanna Scarfone', 'role': 'CONTACT', 'email': 'giovi.scarfone@gmail.com'}, {'name': 'Giovanna Scarfone', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico", 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '20159', 'city': 'Milan', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Margherita Turinetto', 'role': 'CONTACT', 'email': 'margherita.turinetto@sanpiox.humanitas.it'}, {'name': 'Margherita Turinetto', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Humanitas San Pio X - Milano', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '30035', 'city': 'Mirano', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Alessandra Baldoni', 'role': 'CONTACT', 'email': 'alessandra.baldoni@aulss3.veneto.it'}, {'name': 'Alessandra Baldoni', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Presidio Ospedaliero di Mirano', 'geoPoint': {'lat': 45.49458, 'lon': 12.10775}}, {'zip': '20900', 'city': 'Monza', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Robert Fruscio', 'role': 'CONTACT', 'email': 'robert.fruscio@unimib.it'}, {'name': 'Robert Fruscio', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Fondazione IRCCS San Gerardo dei Tintori', 'geoPoint': {'lat': 45.58005, 'lon': 9.27246}}, {'zip': '80131', 'city': 'Napoli', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Jole Ventriglia', 'role': 'CONTACT', 'email': 'j.ventriglia@istitutotumori.na.it'}, {'name': 'Jole Ventriglia', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Istituto Nazionale Tumori Fondazione G. 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Gemelli, IRCCS'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}