Experiences After Risk-Reducing Mastectomy in BRCA1/2 Carriers
Official title: Patient Experiences After Risk-Reducing Mastectomy Among Women Carrying BRCA1/2 Pathogenic Variants Without a Diagnosis of Breast Cancer
Run by Fondazione IRCCS Policlinico San Matteo di Pavia · NCT07821593 · Data updated 2026-11-12
This study asks women with BRCA1/2 or related variants who had risk-reducing mastectomy to share their experiences and satisfaction to see what factors are connected to how happy they are with the outcome.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 25 Years to 70 Years |
| Sex | Women only |
| Enrollment | 100 (estimated) |
| Sponsor | Fondazione IRCCS Policlinico San Matteo di Pavia Academic / other |
| Locations | 1 site (Pavia, Pavia) |
| Status | Recruiting |
| Started | May 1, 2025 |
| Main results expected | September 30, 2026 |
| Study ends | December 2026 |
| Registry record updated | September 16, 2026 |
| Trial ID | NCT07821593 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 18 or older who carry a pathogenic variant associated with hereditary breast and ovarian cancer and have undergone risk-reducing mastectomy, with capacity to consent and complete the survey.
✕Probably not a fit
Individuals who did not undergo mastectomy, lack of a pathogenic variant, or inability to complete the survey may not benefit from the study findings.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a descriptive, cross-sectional observational study conducted at a single center in Italy. It uses a REDCap-based interview sent to participants’ email addresses to collect data on motivations for MRR, surgical and reconstructive details, postoperative issues, and psychosocial outcomes. The analysis will explore relationships between satisfaction and variables such as body image, couple support, sexuality, and recovery experiences. The study aims to provide insight into patient-reported outcomes after preventive mastectomy in hereditary cancer syndrome carriers. Participation is limited to adult female BRCA1/2 or other pathogenic variant carriers who have undergone MRR and provided informed consent.
Why it matters
Potential benefit: If successful, the study could inform patient counseling and support services to improve satisfaction and quality of life after risk-reducing mastectomy.
How similar studies have gone: Previous research suggests variability in satisfaction after risk-reducing mastectomy and supports the value of patient-reported outcomes in this area.
Who can join: the full rules
Show full inclusion / exclusion criteria
* Female patients aged 18 years or older. * Carriers of pathogenic variants associated with hereditary breast and ovarian cancer syndromes (e.g., BRCA1, BRCA2, or other clinically relevant variants). * Having previously undergone risk-reducing mastectomy (MRR). * Being followed or previously evaluated at the clinical center participating in the study. * Ability to understand the study information and complete the survey. * Provision of written informed consent for participation in the study. * Inability to understand or complete the questionnaire. * Refusal or inability to provide informed consent. * Incomplete or missing responses to the survey preventing adequate evaluation of the study outcomes.
Where it's running
-
Fondazione IRCCS Policlinico San Matteo di Pavia
Pavia, Pavia, Italy Recruiting
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
AirGo Respiratory Monitoring During Lung Resection
Patients undergoing lung resection will wear the AirGo device to continuously monitor breathing before and after surgery to see if it helps track ventilation alongside standard checks.
-
Natural history of eosinophilic esophagitis in adults and children
This observational study tests how eosinophilic esophagitis progresses over time in people 5 years and older to understand symptoms and outcomes.
-
COVID-19 Registry at San Matteo (SMACORE) - patient-matching observational registry
This registry tests how COVID-19 patients are being treated and progress across San Matteo in Pavia to understand patterns and outcomes.
-
Registry of Transcatheter Aortic Valve Treatments at a Italian Center
This registry tests how safe and effective transcatheter valve procedures are in adults with severe aortic stenosis treated at a single Italian center.
-
Systemic Vasculitis Prognosis and Outcome
This study follows patients suspected or diagnosed with systemic vasculitis over 10 years to see how their disease progresses and what factors predict outcomes.
-
Monitoring remission and planned drug tapering in early rheumatoid arthritis
This registry will follow adults with early rheumatoid arthritis who are in stable remission on conventional DMARDs to see if tapering or stopping those drugs is safe and how often disease returns.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.