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RECRUITING
NCT07253051

BRCA Mutation Carriers' Platform a Multicenter Study

Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

View on ClinicalTrials.gov

Summary

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. Since 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.

Official title: BRCA Mutation Carriers' Platform, a Multicenter Study

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

10000

Start Date

2025-04-05

Completion Date

2045-12-31

Last Updated

2025-11-28

Healthy Volunteers

No

Interventions

OTHER

Registration of clinical datas in the platform

Registration of clinical datas in the platform of female individual carrying a BRCA1 or BRCA2 mutation

Locations (40)

Malzoni Research Hospital

Avellino, Italy

Centro di Riferimento Oncologico IRCCS

Aviano, Italy

Università degli Studi di Bari "Aldo Moro"

Bari, Italy

IRCCS Istituto Tumori "Giovanni Paolo II"

Bari, Italy

ASST Papa Giovanni XXIII

Bergamo, Italy

L'Azienda ospedaliera per l'emergenza "Cannizzaro"

Catania, Italy

Azienda Ospedaliero Santa Croce e Carle

Cuneo, Italy

Presidio Ospedaliero Umberto I - ASP di Enna

Enna, Italy

Azienda Ospedaliero Universitaria Careggi, Oncologia Medica Ginecologica

Florence, Italy

IRCCS Ospedale Policlinico San Martino

Genova, Italy

Ospedale S. Maria Goretti, Latina

Latina, Italy

Ospedale del Tigullio Polo di Lavagna - ASL 4 Chiavarese

Lavagna, Italy

Ospedale Vito Fazzi, Lecce

Lecce, Italy

Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori"

Meldola, Italy

IRCCS Ospedale San Raffaele

Milan, Italy

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, Italy

Humanitas San Pio X - Milano

Milan, Italy

Presidio Ospedaliero di Mirano

Mirano, Italy

Fondazione IRCCS San Gerardo dei Tintori

Monza, Italy

Istituto Nazionale Tumori Fondazione G. Pascale

Naples, Italy

Ospedale Mater Olbia

Olbia, Italy

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

Palermo, Italy

Azienda Ospedaliera Universitaria di Parma

Parma, Italy

Azienda Ospedaliero-Universitaria di Parma

Parma, Italy

Centro Nazionale di Adroterapia Oncologica

Pavia, Italy

Fondazione I.R.C.C.S. Policlinico San Matteo

Pavia, Italy

Azienda Ospedaliero Universitaria Pisana

Pisa, Italy

Istituto Nazionale Tumori Regina Elena

Roma, Italy

Istituto Nazionale Tumori Regina Elena

Roma, Italy

Policlinico Umberto I Università "La Sapienza"

Roma, Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS, UOC Ginecologia Oncologica

Rome, Italy

Azienda Ospedaliera Universitaria Senese

Siena, Italy

Ospedale G. Mazzini di Teramo

Teramo, Italy

Azienda sanitaria universitaria Friuli Centrale

Tolmezzo, Italy

Azienda Ospedaliero Universitaria Citta della Salute e della Scienza di Torino

Torino, Italy

Ospedale Mauriziano Umberto I

Torino, Italy

Azienda ULSS 2 MARCA TREVIGIANA

Treviso, Italy

IRCCS materno infantile Burlo Garofolo

Trieste, Italy

Azienda Ospedaliera Universitaria Integrata

Verona, Italy

AULSS 8 Berica

Vicenza, Italy