Evaluating cancer prevention strategies for women with BRCA1-2 mutations in Italy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational cohort study aims to centralize data on cancer prevention strategies for women carrying deleterious mutations in the BRCA1 and BRCA2 genes. It includes both retrospective and prospective cohorts of women aged 18 and older, with or without a history of breast cancer, who have been admitted to participating centers. The study will assess various risk-reducing strategies, including surveillance, chemoprevention, and prophylactic surgeries, to better understand their effectiveness and impact on patient outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Cohort A (Retrospective):

1. Female sex
2. Age ≥ 18 years
3. Signed informed consent
4. Documented germline deleterious mutation in BRCA1 and/or BRCA2 in people with: i) No history of cancer ii) Radically treated breast cancer iii) Stage IV breast cancer diagnosed after BRCA1-2 mutation detection
5. Admission to the participating Center since 1st of January 2010, prior to site activation

Cohort B (Prospective):

1. Female sex
2. Age ≥ 18 years
3. Signed informed consent
4. Documented germline deleterious mutation in BRCA1 and/or BRCA2 in people with: i) No history of cancer ii) Radically treated breast cancer iii) Stage IV breast cancer diagnosed after BRCA1-2 mutation detection
5. Admission to the participating Center after site activation

Exclusion Criteria:

Cohort A/B (Retrospective/Prospective):

1\. Other malignancies diagnosed within five years prior to BRCA1-2 mutation detection, except for:

* ovarian cancer stage I-II
* basal or squamous cell carcinoma of the skin
* melanoma in situ
* CIS of the cervix

Where it's running

• Centro di Riferimento Oncologico - Aviano
  Aviano, Pordenone, Italy Recruiting
• IRCCS AOU San Martino, IST Genova
  Genova, Italy Recruiting
• Azienda Ospedaliera Papardo
  Messina, Italy Recruiting
• ASST Ovest Milanese
  Milan, Italy Recruiting
• Azienda ospedaliera Universitaria di Modena
  Modena, Italy Recruiting
• Università degli studi di Napoli Federico II
  Naples, Italy Recruiting

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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.