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Идёт набор NCT05162677

Prophylactic Mastectomy: Prospective Evaluation of the Correlation Between Skin Flap Thickness, Residual Glandular Tissue and Skin Necrosis by Imaging and Clinical Examination

— Наблюдательное Prophylactic Mastectomy

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Prophylactic Mastectomy. Базовые параметры: 18 лет — 74 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Швеция
Следующий шаг
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Обзор

Breast cancer is the most common form of cancer among women. Five to ten percent of all breast cancers are due to hereditary factors, with pathogenic variants in the breast cancer genes BRCA1/2 accounting for 2-5% of all breast cancer. Women with pathogenic variants in BRAC1/2 and other pathogenic gene mutations leading to an increased risk of breast cancer can undergo prophylactic mastectomy, reducing the risk of breast cancer up to 90%. Among women who have undergone prophylactic mastectomy, 1-1,9% are diagnosed with breast cancer, but little is known about the correlation between residual glandular tissue and skin flap thickness, as well as the oncological risk of residual glandular tissue. Furthermore, there is a balance between how much subcutaneous tissue should be resected to achieve maximal reduction of glandular tissue, while leaving viable skin flaps. In addition, there are established surveillance guidelines for women with pathogenic variants in BRCA1/2 who do not undergo risk-reducing surgery, but no published consensus or guidelines regarding appropriate medical follow-up for those who opt for prophylactic mastectomy. The aim of this study is to investigate the correlation between skin flap thickness, residual glandular tissue and skin flap necrosis following prophylactic mastectomy in women with results from postoperative magnetic resonance tomography, ultrasound and physical examination, as well as evaluate patient satisfaction and quality of life pre- and postoperatively with different questionnaires.

Первичные конечные точки

  • Presence of residual glandular tissue [Срок оценки: Residual glandular tissue will be evaluated 1 year postoperatively]
  • Presence of residual glandular tissue [Срок оценки: Residual glandular tissue will be evaluated 3 years postoperatively]
  • Measurement of skin flap thickness [Срок оценки: Skin flap thickness will be evaluated 1 year postoperatively]
  • Measurement of skin flap thickness [Срок оценки: Skin flap thickness will be evaluated 3 years postoperatively]
Вторичные конечные точки (5)
  • Change in evaluation of patient satisfaction [Срок оценки: Change in patient satisfaction will be evaluated pre- and postoperatively. The women will receive the questionnaires 1 month preoperatively, 1 year postoperatively and 3 years postoperatively.]
  • Change in evaluation of patient quality of life [Срок оценки: Change in patient quality of life will be evaluated pre- and postoperatively. The women will receive the questionnaires 1 month preoperatively, 1 year postoperatively and 3 years postoperatively.]
  • Number of participants with acute postoperative complications [Срок оценки: Clinical examination will be performed 2-4 weeks postoperatively.]
  • Number of participants with long term postoperative complications [Срок оценки: Clinical examination will be performed 1 year postoperatively.]
  • Number of participants with long term postoperative complications [Срок оценки: Clinical examination will be performed 3 years postoperatively.]

Критерии участия

Критерии включения

  • Women that are recommended prophylactic mastectomy at the Department of Plastic Surgery at Umeå University hospital due to hereditary factors that have been investigated by clinical geneticists.
  • Age between 18-74 years

Критерии исключения

  • Women undergoing mastectomy due to cancer.
  • Age < 18 years or > 74 years.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Швеция · 1 центр
  • Plastic Surgery Unit, Umeå University hospital — Umeå

Публикации

  • Wiberg R, Andersson MN, Svensson J, Rosen A, Koch F, Bjorkgren A, Sund M. Prophylactic Mastectomy: Postoperative Skin Flap Thickness Evaluated by MRT, Ultrasound and Clinical Examination. Ann Surg Oncol. 2020 Jul;27(7):2221-2228. doi: 10.1245/s10434-019-08157-2. Epub 2020 Jan 6. PMID 31907748
  • Skoglund MA, Andersson MN, Bjorkgren A, Tolocka E, Sund M, Wiberg R. Inter- and intra-observer agreement on evaluating the presence of residual glandular tissue with magnetic resonance tomography following prophylactic mastectomy. Acta Radiol. 2023 Jan;64(1):67-73. doi: 10.1177/02841851211058929. Epub 2021 Dec 1. PMID 34851154

Идентификаторы

NCT: NCT05162677 · 2021-PrMa-RWiberg

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗