Actively Recruiting

Age: 18Years +
FEMALE
ID07253051

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

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

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

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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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