Clinical trial NCT05162677: Prophylactic Mastectomy: Prospective Evaluation of the Correlation Between Skin Flap Thickness, Residual Glandular Tissue and Skin Necrosis by Imaging and Clinical Examination
Official title: Prophylactic Mastectomy: Prospective Evaluation of the Correlation Between Skin Flap Thickness, Residual Glandular Tissue and Skin Necrosis by Imaging and Clinical Examination
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Prophylactic Mastectomy
Lead sponsor: Umeå University
Sponsor class: OTHER
First posted: 2021-12-17
Enrollment: 45
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All women with elevated risk of developing breast cancer due to hereditary factors that will undergo prophylactic mastectomy at the Department of Plastic Surgery at Umeå University hospital and forfill the inclusion criteria will be invited to the study.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Presence of residual glandular tissue
timeFrame: Residual glandular tissue will be evaluated 1 year postoperatively
measure: Presence of residual glandular tissue
timeFrame: Residual glandular tissue will be evaluated 3 years postoperatively
measure: Measurement of skin flap thickness
timeFrame: Skin flap thickness will be evaluated 1 year postoperatively
measure: Measurement of skin flap thickness
timeFrame: Skin flap thickness will be evaluated 3 years postoperatively
Secondary outcomes:
measure: Change in evaluation of patient satisfaction
timeFrame: 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.
measure: Change in evaluation of patient quality of life
timeFrame: 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.
measure: Number of participants with acute postoperative complications
timeFrame: Clinical examination will be performed 2-4 weeks postoperatively.
measure: Number of participants with long term postoperative complications
timeFrame: Clinical examination will be performed 1 year postoperatively.
measure: Number of participants with long term postoperative complications
timeFrame: Clinical examination will be performed 3 years postoperatively.
Other outcomes:
Locations:
city: Umeå
country: Sweden
facility: Plastic Surgery Unit, Umeå University hospital
Study officials:
References:
citation: 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.
citation: 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.