Platform for women with BRCA1 or BRCA2 mutations in Italy
Official title: BRCA Mutation Carriers' Platform, a Multicenter Study
Run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · NCT07253051 · Data updated 2026-11-12
This project will try to collect clinical and follow-up data from women in Italy who carry pathogenic BRCA1 or BRCA2 mutations to build a national registry that can guide prevention and care.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 10000 (estimated) |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 40 sites (Avellino and 39 other locations) |
| Status | Recruiting |
| Started | April 5, 2025 |
| Main results expected | April 1, 2045 |
| Study ends | December 31, 2045 |
| Registry record updated | November 28, 2025 |
| Trial ID | NCT07253051 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women age 18 or older who are known carriers of pathogenic (class 4 or 5) BRCA1 or BRCA2 mutations are the intended participants.
✕Probably not a fit
People who do not carry a pathogenic BRCA1/2 mutation, males, and individuals under 18 are not eligible and are unlikely to gain direct benefit from joining.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicenter observational platform will prospectively register clinical, surgical, and follow-up data from adult women with pathogenic BRCA1 or BRCA2 mutations. Participants are recruited at several Italian oncology centers and data are entered into a centralized database to harmonize management and outcomes. The platform aims to generate real-world evidence on cancer risk, prevention strategies, and treatment patterns among BRCA carriers in Italy. Collected data can support more accurate risk estimates, inform national guidance, and identify candidates for preventive interventions.
Why it matters
Potential benefit: If successful, the registry could improve prevention decisions and personalize follow-up and treatment for BRCA mutation carriers across Italy.
How similar studies have gone: International registries and cohort studies of BRCA carriers have produced useful risk and prevention data, but a coordinated prospective national platform in Italy is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Age \< 18 years old; * No pathogenetic mutation carriers.
Where it's running
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IRCCS Istituto Tumori "Giovanni Paolo II"
Bari, Italy Recruiting -
Fondazione IRCCS San Gerardo dei Tintori
Monza, Italy Recruiting -
Istituto Nazionale Tumori Fondazione G. Pascale
Naples, Italy Recruiting -
Fondazione Policlinico Universitario Agostino Gemelli IRCCS, UOC Ginecologia Oncologica
Rome, Italy Recruiting -
Malzoni Research Hospital
Avellino, Italy Not yet recruiting -
Centro di Riferimento Oncologico IRCCS
Aviano, Italy Not yet recruiting
Show 34 more locations
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Università degli Studi di Bari "Aldo Moro"
Bari, Italy Not yet recruiting -
ASST Papa Giovanni XXIII
Bergamo, Italy Not yet recruiting -
L'Azienda ospedaliera per l'emergenza "Cannizzaro"
Catania, Italy Not yet recruiting -
Azienda Ospedaliero Santa Croce e Carle
Cuneo, Italy Not yet recruiting -
Presidio Ospedaliero Umberto I - ASP di Enna
Enna, Italy Not yet recruiting -
Azienda Ospedaliero Universitaria Careggi, Oncologia Medica Ginecologica
Florence, Italy Not yet recruiting -
IRCCS Ospedale Policlinico San Martino
Genova, Italy Not yet recruiting -
Ospedale S. Maria Goretti, Latina
Latina, Italy Not yet recruiting -
Ospedale del Tigullio Polo di Lavagna - ASL 4 Chiavarese
Lavagna, Italy Not yet recruiting -
Ospedale Vito Fazzi, Lecce
Lecce, Italy Not yet recruiting -
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori"
Meldola, Italy Not yet recruiting -
IRCCS Ospedale San Raffaele
Milan, Italy Not yet recruiting -
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Italy Not yet recruiting -
Humanitas San Pio X - Milano
Milan, Italy Not yet recruiting -
Presidio Ospedaliero di Mirano
Mirano, Italy Not yet recruiting -
Ospedale Mater Olbia
Olbia, Italy Not yet recruiting -
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Palermo, Italy Not yet recruiting -
Azienda Ospedaliera Universitaria di Parma
Parma, Italy Not yet recruiting -
Azienda Ospedaliero-Universitaria di Parma
Parma, Italy Not yet recruiting -
Centro Nazionale di Adroterapia Oncologica
Pavia, Italy Not yet recruiting -
Fondazione I.R.C.C.S. Policlinico San Matteo
Pavia, Italy Not yet recruiting -
Azienda Ospedaliero Universitaria Pisana
Pisa, Italy Not yet recruiting -
Istituto Nazionale Tumori Regina Elena
Roma, Italy Not yet recruiting -
Istituto Nazionale Tumori Regina Elena
Roma, Italy Not yet recruiting -
Policlinico Umberto I Università "La Sapienza"
Roma, Italy Not yet recruiting -
Azienda Ospedaliera Universitaria Senese
Siena, Italy Not yet recruiting -
Ospedale G. Mazzini di Teramo
Teramo, Italy Not yet recruiting -
Azienda sanitaria universitaria Friuli Centrale
Tolmezzo, Italy Not yet recruiting -
Azienda Ospedaliero Universitaria Citta della Salute e della Scienza di Torino
Torino, Italy Not yet recruiting -
Ospedale Mauriziano Umberto I
Torino, Italy Not yet recruiting -
Azienda ULSS 2 MARCA TREVIGIANA
Treviso, Italy Not yet recruiting -
IRCCS materno infantile Burlo Garofolo
Trieste, Italy Not yet recruiting -
Azienda Ospedaliera Universitaria Integrata
Verona, Italy Not yet recruiting -
AULSS 8 Berica
Vicenza, Italy Not yet recruiting
Study contacts
- Principal investigator: Anna Fagotti — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study coordinator: Anna Fagotti
- Email: anna.fagotti@policlinicogemelli.it
- Phone: +390630157004
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.