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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.

Överblick

Status
Rekrytering
Sponsor
Sir Mortimer B. Davis - Jewish General Hospital
Inskrivningsmål
4,700
Starta
01 feb 2025
Beräknad slutförande
01 feb 2028
Breast Cancer Surgery

Vad handlar denna studie om?

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.

Viktiga punkter

  • 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.

Vem kan vara berättigad?

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.

Kan denna studie passa dig?

Svara på dessa snabba frågor för att se om du kan vara berättigad. Detta är endast en vägledning — forskarteamet fattar det slutgiltiga beslutet.

  1. I am a woman and was assigned female at birth.
  2. Jag är 18 år gammal eller äldre.
  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.
Svara på varje fråga för att se ditt resultat.

Vad innebär deltagande?

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.

Potentiella risker och fördelar

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.

Platser (16)

  • Yale Universitet
    Verifierat postnummer
    New Haven, USA· Rekrytering
  • Brigham and Women's Hospital - Dana-Farber Brigham Cancer Center
    Verifierat postnummer
    Boston, USA· Rekryterar inte ännu
  • Memorial Sloan Kettering Cancer Center (MSKCC)
    Verifierat postnummer
    New York, USA· Rekryterar inte ännu
  • University of Rochester, Wilmot Cancer Institute
    Verifierat postnummer
    Rochester, USA· Rekryterar inte ännu
  • University of Pennsylvania
    Verifierat postnummer
    Philadelphia, USA· Rekrytering
  • University of Melbourne, Peter MacCallum Cancer Center
    Verifierat postnummer
    Melbourne, Australien· Rekryterar inte ännu
  • Ziekenhuis Aan de Stroom
    Verifierat postnummer
    Antwerpen, Belgien· Aktiv men inte rekryterande
  • Universitetet i Calgary
    Verifierat postnummer
    Calgary, Kanada· Rekrytering
  • Hamilton Health Sciences
    Verifierat postnummer
    Hamilton, Kanada· Rekrytering
  • Women's College Hospital, University of Toronto
    Verifierat postnummer
    Toronto, Kanada· Rekryterar inte ännu
  • Judiska Allmänna Sjukhuset
    Verifierat postnummer
    Montreal, Kanada· Rekrytering
  • CHU de Quebec Université laval
    Verifierat postnummer
    Québec, Kanada· Rekrytering

Vanliga frågor

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.

Varför är denna studie viktig?

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.

Kommer jag att få en ny behandling i denna studie?

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.

Hur du får reda på mer

Stephanie Wong, MD

sm.wong@mcgill.ca 5143408222 Officiell rättegångsprotokoll

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