Actively Recruiting
BRCA Mutation Carriers' Platform, a Multicenter Study
Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2025-11-28
10000
Participants Needed
40
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying women who carry mutations in the breast cancer susceptibility genes BRCA1 and BRCA2 to better understand their risk of developing cancer. This observational study aims to collect national data from women with these mutations, as current management strategies are not fully established. The study focuses on the Italian population, where an estimated 140,000 to 150,000 women carry these mutations, and many face a high lifetime risk of genetically linked tumors. Participants will be registered on a platform where their clinical data related to BRCA1 or BRCA2 mutations will be collected. The study does not involve treatment but gathers detailed information about mutation distribution, access to genetic evaluation, lifestyle risk factors, preventive strategies, and surgical risk reduction approaches such as salpingo-oophorectomy. Women in the study will provide data that researchers will analyze to understand mutation geography, related cancer types, and screening criteria. Data collection occurs over different time frames, including immediate and six-month intervals. The study continues through long-term observation to monitor outcomes and preventive efforts, with no active intervention applied to participants.
CONDITIONS
Brief Title
BRCA Mutation Carriers' Platform a Multicenter Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women 18 years of age or older
- Known carriers of pathogenic class 4 or 5 mutations in the BRCA1 or BRCA2 genes
You will not qualify if you...
- Age under 18 years
- Not carriers of pathogenic BRCA1 or BRCA2 mutations
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 months
Participants who are carriers of BRCA1 or BRCA2 mutations are observed with registration of clinical data in the platform.
1 visit (in-person) for data collection
Trial Site Locations
Total: 40 locations
1
Malzoni Research Hospital
Avellino, Italy, 83100
Not Yet Recruiting
2
Centro di Riferimento Oncologico IRCCS
Aviano, Italy, 33081
Not Yet Recruiting
3
Università degli Studi di Bari "Aldo Moro"
Bari, Italy, 70121
Not Yet Recruiting
4
IRCCS Istituto Tumori "Giovanni Paolo II"
Bari, Italy, 70124
Actively Recruiting
5
ASST Papa Giovanni XXIII
Bergamo, Italy, 24127
Not Yet Recruiting
6
L'Azienda ospedaliera per l'emergenza "Cannizzaro"
Catania, Italy, 95126
Not Yet Recruiting
7
Azienda Ospedaliero Santa Croce e Carle
Cuneo, Italy, 12100
Not Yet Recruiting
8
Presidio Ospedaliero Umberto I - ASP di Enna
Enna, Italy, 94100
Not Yet Recruiting
9
Azienda Ospedaliero Universitaria Careggi, Oncologia Medica Ginecologica
Florence, Italy, 50134
Not Yet Recruiting
10
IRCCS Ospedale Policlinico San Martino
Genova, Italy, 16132
Not Yet Recruiting
11
Ospedale S. Maria Goretti, Latina
Latina, Italy, 04100
Not Yet Recruiting
12
Ospedale del Tigullio Polo di Lavagna - ASL 4 Chiavarese
Lavagna, Italy, 16033
Not Yet Recruiting
13
Ospedale Vito Fazzi, Lecce
Lecce, Italy, 73100
Not Yet Recruiting
14
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori"
Meldola, Italy, 47014
Not Yet Recruiting
15
IRCCS Ospedale San Raffaele
Milan, Italy, 20132
Not Yet Recruiting
16
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Italy, 20133
Not Yet Recruiting
17
Humanitas San Pio X - Milano
Milan, Italy, 20159
Not Yet Recruiting
18
Presidio Ospedaliero di Mirano
Mirano, Italy, 30035
Not Yet Recruiting
19
Fondazione IRCCS San Gerardo dei Tintori
Monza, Italy, 20900
Actively Recruiting
20
Istituto Nazionale Tumori Fondazione G. Pascale
Naples, Italy, 80131
Actively Recruiting
21
Ospedale Mater Olbia
Olbia, Italy, 07026
Not Yet Recruiting
22
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Palermo, Italy, 90127
Not Yet Recruiting
23
Azienda Ospedaliera Universitaria di Parma
Parma, Italy, 43126
Not Yet Recruiting
24
Azienda Ospedaliero-Universitaria di Parma
Parma, Italy, 43126
Not Yet Recruiting
25
Centro Nazionale di Adroterapia Oncologica
Pavia, Italy, 27100
Not Yet Recruiting
26
Fondazione I.R.C.C.S. Policlinico San Matteo
Pavia, Italy, 27100
Not Yet Recruiting
27
Azienda Ospedaliero Universitaria Pisana
Pisa, Italy, 56100
Not Yet Recruiting
28
Istituto Nazionale Tumori Regina Elena
Roma, Italy, 00144
Not Yet Recruiting
29
Istituto Nazionale Tumori Regina Elena
Roma, Italy, 00144
Not Yet Recruiting
30
Policlinico Umberto I Università "La Sapienza"
Roma, Italy, 00161
Not Yet Recruiting
31
Fondazione Policlinico Universitario Agostino Gemelli IRCCS, UOC Ginecologia Oncologica
Rome, Italy, 00168
Actively Recruiting
32
Azienda Ospedaliera Universitaria Senese
Siena, Italy, 53100
Not Yet Recruiting
33
Ospedale G. Mazzini di Teramo
Teramo, Italy, 64100
Not Yet Recruiting
34
Azienda sanitaria universitaria Friuli Centrale
Tolmezzo, Italy, 33028
Not Yet Recruiting
35
Azienda Ospedaliero Universitaria Citta della Salute e della Scienza di Torino
Torino, Italy, 10126
Not Yet Recruiting
36
Ospedale Mauriziano Umberto I
Torino, Italy, 10128
Not Yet Recruiting
37
Azienda ULSS 2 MARCA TREVIGIANA
Treviso, Italy, 31100
Not Yet Recruiting
38
IRCCS materno infantile Burlo Garofolo
Trieste, Italy, 34137
Not Yet Recruiting
39
Azienda Ospedaliera Universitaria Integrata
Verona, Italy, 37126
Not Yet Recruiting
40
AULSS 8 Berica
Vicenza, Italy, 36100
Not Yet Recruiting
Research Team
A
Anna Fagotti
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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