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The question after preventive mastectomy: would women do it again?

NCT ID NCT07821593

Knowledge-focused Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 16, 2026 · Last updated Sep 17, 2026 · Updated 1 time

Summary

Researchers at an Italian hospital are asking women who carry BRCA1/2 gene variants and chose risk-reducing mastectomy to describe their experience in an online survey. The survey covers why they chose surgery, which procedures and reconstructions they had, complications, sensation changes, partner support, sexuality, body image, and overall quality of life. The goal is to understand what shapes satisfaction with the decision and whether women would recommend the same path to others.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If the survey captures what women value and regret about preventive mastectomy, clinics could tailor counseling and follow-up care to those concerns.
What could go wrong
This is a single-center survey of 100 women, so the answers may reflect one hospital's surgical practices and may not apply to patients elsewhere. Surveys also capture what people say about their experience, not objective medical outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

he study population consists of women carrying pathogenic variants associated with hereditary breast and ovarian cancer syndromes who have undergone risk-reducing mastectomy (MRR). Participants will be identified among patients previously followed at the clinical center participating in the study and who have provided informed consent to participate. Eligible participants will be invited to complete an online survey developed on the REDCap platform, which will be sent to their personal email address. The survey is designed to collect information regarding their experiences following preventive mastectomy, including satisfaction with the surgical decision, body image perception, quality of life, and relational and psychosocial aspects related to the surgical experience. The study therefore focuses on patient-reported outcomes in women who have undergone preventive breast surgery due to hereditary cancer risk.

Ages

25 to 70 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

* 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.

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Conditions

The condition(s) this trial relates to.

hereditary breast ovarian cancer syndrome hereditary neoplastic syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Heredo familial tumors Psycho oncological support

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Fondazione IRCCS Policlinico San Matteo di Pavia

    RECRUITING

    Pavia, Pavia, 27100, Italy

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