NCT05162677 Prophylactic Mastectomy: Prospective Evaluation of the Correlation Between Skin Flap Thickness, Residual Glandular Tissue and Skin Necrosis by Imaging and Clinical Examination
| NCT ID | NCT05162677 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Umeå University |
| Condition | Prophylactic Mastectomy |
| Study Type | OBSERVATIONAL |
| Enrollment | 45 participants |
| Start Date | 2022-08-25 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 45 participants in total. It began in 2022-08-25 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05162677 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 74 Years, studying Prophylactic Mastectomy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05162677 currently recruiting?
Yes, NCT05162677 is actively recruiting participants. Contact the research team at rebecka.wiberg@umu.se for enrollment information.
Where is the NCT05162677 trial being conducted?
This trial is being conducted at Umeå, Sweden.
Who is sponsoring the NCT05162677 clinical trial?
NCT05162677 is sponsored by Umeå University. The trial plans to enroll 45 participants.