BRCA Mutation Carriers' Platform a Multicenter Study

Recruiting now

Conditions studied: BRCA1 Mutation, BRCA2 Mutation

In brief

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.

Key facts

Study ID

NCT07253051

Run by

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

People needed

10000

Starts

2025-04-05

Expected to finish

2045-12-31

Last updated by the study team

2025-11-28

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• All women who are 18 years of age or older;
• 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.

You may not qualify if…

• Age < 18 years old;
• No pathogenetic mutation carriers.

Where it is running

• Istituto Nazionale Tumori Fondazione G. Pascale — Naples, Italy (enrolling)
• IRCCS Istituto Tumori "Giovanni Paolo II" — Bari, Italy (enrolling)
• Fondazione Policlinico Universitario Agostino Gemelli IRCCS, UOC Ginecologia Oncologica — Rome, Italy (enrolling)
• Fondazione IRCCS San Gerardo dei Tintori — Monza, Italy (enrolling)
• 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
• 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

Full record on ClinicalTrials.gov

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