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Platform for women with BRCA1 or BRCA2 mutations in Italy

BRCA Mutation Carriers' Platform, a Multicenter Study

Observational Fondazione Policlinico Universitario Agostino Gemelli IRCCS · NCT07253051

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
Enrollment10000 (estimated)
Ages18 Years and up
SexFemale
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other
Locations40 sites (Avellino and 39 other locations)
Trial IDNCT07253051 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility criteria

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 this trial is running

Avellino and 39 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions BRCA1 MutationBRCA2 Mutation
Last reviewed 2026-06-13 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.