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Long-term Safety of Nipple Sparing Mastectomy in Women With High Penetrance Breast Cancer Susceptibility Genes in Breast Cancer

This study is investigating the long-term safety of a type of breast surgery called nipple-sparing mastectomy. This operation allows women at high genetic risk of breast cancer to have a mastectomy (breast removal) to reduce their risk, while also keeping their nipple and the darker skin around it (areola). Many women prefer this option for their body image and well-being, but there isn't much long-term information yet on how safe it is, especially for preventing future cancers when compared to other types of mastectomy. This research aims to provide more clear answers by following women with specific genetic changes for a longer time, helping doctors give the best advice.

Auf einen Blick

Status
Rekrutierung
Sponsor
Sir Mortimer B. Davis - Jewish General Hospital
Einschreibeziel
4,700
Starten
01 Feb 2025
Geschätzte Fertigstellung
01 Feb 2028

Worum geht es in dieser Studie?

Imagine you have a strong family history of breast cancer, or genetic test results show you have a higher chance of developing it. One option some women consider is surgery to remove their breasts to significantly lower this risk. This is called a risk-reducing mastectomy.

There are different ways to do this surgery. Historically, the nipple and the skin around it were removed. However, a newer technique called 'nipple-sparing mastectomy' allows surgeons to remove the breast tissue, but keep the nipple and areola intact. Many women find that keeping these parts of their breast helps them feel much better about their body and reduces feelings of disfigurement after surgery.

Even though nipple-sparing mastectomy can have these important benefits for a woman's well-being, doctors still need more long-term information to be absolutely sure it's as safe as other types of mastectomy for cancer prevention, especially for women with certain genetic risks. This study aims to gather that important long-term safety data. By following women for a longer time, researchers hope to confirm whether this type of surgery is just as effective at preventing breast cancer in those at high genetic risk.

Wichtige Erkenntnisse

  • The study explores the long-term safety of nipple-sparing mastectomy.
  • It's for women with specific genetic risks for breast cancer.
  • The goal is to provide clearer evidence on this surgery for cancer prevention.
  • Many women prefer this surgery for body image.
  • More long-term data is needed for medical guidelines.

Wer könnte berechtigt sein?

This study is looking for women who were assigned female at birth and are 18 years old or older. You would need to have had a genetic test that confirmed you carry specific changes in certain genes known to increase the risk of breast cancer. These genes include BRCA1, BRCA2, PALB2, TP53, CDH1, or PTEN.

You wouldn't be able to join if you have already had breast cancer, or if you had ovarian cancer before your genetic testing. Also, if you've already had both breasts removed before your genetic test, you wouldn't be suitable for this study. Finally, if your genetic test showed a 'variant of uncertain significance' – meaning genetic changes whose role isn't yet fully understood – as your only genetic finding, this study wouldn't be right for you.

Könnte diese Studie für Sie geeignet sein?

Beantworten Sie diese kurzen Fragen, um zu sehen, ob Sie möglicherweise berechtigt sind. Dies ist nur ein Leitfaden – das Forschungsteam trifft die endgültige Entscheidung.

  1. I am a woman and was assigned female at birth.
  2. Ich bin 18 Jahre alt oder älter.
  3. I have had a genetic test that confirmed a specific genetic change (like BRCA1 or BRCA2) that increases my breast cancer risk.
  4. I have never had breast cancer before my genetic test.
  5. I have never had ovarian cancer before my genetic test.
  6. I have not had both breasts removed before my genetic test.
Beantworten Sie jede Frage, um Ihr Ergebnis zu sehen.

Was beinhaltet die Teilnahme?

The description does not provide details on what participation would involve in terms of visits, assessments, medication, or specific follow-up schedules. It mentions a focus on longer follow-up to confirm previous findings. To get a clear understanding of what joining this study would mean for you, you would need to speak directly with the research team.

Potenzielle Risiken und Vorteile

Participating in research studies like this can often provide important information that helps future patients. A potential benefit of this study is contributing to a better understanding of the long-term safety of nipple-sparing mastectomy for women with specific genetic risks, which could help many others make informed choices. The study itself is observational, meaning it's likely to involve collecting information rather than new treatments. While the specific risks of participation are not detailed here, generally, these might include time commitment for appointments or potential emotional impact when discussing medical history. You always have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Standorte (16)

  • Universität Yale
    Verifizierte Postleitzahl
    New Haven, Vereinigte Staaten· Rekrutierung
  • Brigham and Women's Hospital - Dana-Farber Brigham Cancer Center
    Verifizierte Postleitzahl
    Boston, Vereinigte Staaten· Noch nicht rekrutiert
  • Memorial Sloan Kettering Cancer Center (MSKCC)
    Verifizierte Postleitzahl
    New York, Vereinigte Staaten· Noch nicht rekrutiert
  • University of Rochester, Wilmot Cancer Institute
    Verifizierte Postleitzahl
    Rochester, Vereinigte Staaten· Noch nicht rekrutiert
  • Universität von Pennsylvania
    Verifizierte Postleitzahl
    Philadelphia, Vereinigte Staaten· Rekrutierung
  • University of Melbourne, Peter MacCallum Cancer Center
    Verifizierte Postleitzahl
    Melbourne, Australia· Noch nicht rekrutiert
  • Ziekenhuis Aan de Stroom
    Verifizierte Postleitzahl
    Antwerp, Belgium· Aktiv, aber nicht rekrutierend
  • University of Calgary
    Verifizierte Postleitzahl
    Calgary, Kanada· Rekrutierung
  • Hamilton Gesundheitswissenschaften
    Verifizierte Postleitzahl
    Hamilton, Kanada· Rekrutierung
  • Women's College Hospital, University of Toronto
    Verifizierte Postleitzahl
    Toronto, Kanada· Noch nicht rekrutiert
  • Jewish General Hospital
    Verifizierte Postleitzahl
    Montreal, Kanada· Rekrutierung
  • CHU de Quebec Université laval
    Verifizierte Postleitzahl
    Québec, Canada· Rekrutierung

Häufige Fragen

What is a 'nipple-sparing mastectomy'?

It's a type of surgery where breast tissue is removed to reduce cancer risk, but the nipple and the darker skin around it (areola) are kept.

Warum ist diese Studie wichtig?

It aims to confirm if nipple-sparing mastectomy is a safe long-term option for preventing breast cancer in women with certain genetic risks, especially since many prefer this surgery for their well-being.

Who can take part in this research?

Women aged 18 or over, who have specific genetic changes (like in BRCA1/2 genes) that increase their breast cancer risk, and who haven't had breast or ovarian cancer before their genetic testing.

What genes are they looking at?

The study is looking at women with changes in genes like BRCA1, BRCA2, PALB2, TP53, CDH1, or PTEN.

Werde ich in dieser Studie eine neue Behandlung erhalten?

The study focuses on observing outcomes over time for women who have already had or are considering a nipple-sparing mastectomy, rather than providing a new treatment.

Wie Sie mehr erfahren können

Stephanie Wong, MD

Sprechen Sie immer mit Ihrem Hausarzt oder Spezialisten, bevor Sie sich entscheiden, an einer Studie teilzunehmen.

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