Clinical trial Recruiting at 4 sites Observational Ages 18 and up Women only

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 typeObservational
Ages18 Years and up
SexWomen only
Enrollment10000 (estimated)
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS
Academic / other
Locations40 sites (Avellino and 39 other locations)
StatusRecruiting
StartedApril 5, 2025
Main results expectedApril 1, 2045
Study endsDecember 31, 2045
Registry record updatedNovember 28, 2025
Trial IDNCT07253051 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

  • 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
  • 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

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.