Prophylactic MastectomyNCT05162677
Prophylactic Mastectomy: Prospective Evaluation of the Correlation Between Skin Flap Thickness, Residual Glandular Tissue and Skin Necrosis by Imaging and Clinical Examination
An observational study of Prophylactic Mastectomy, run by Umeå University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 74 years, women only
- Conditions the study is for
- Prophylactic Mastectomy
- How many people
- 45 participants
- Where
- 1 siteSweden
- Study dates
- 25 Aug 2022to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- Women only
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Women undergoing mastectomy due to cancer.
- Age < 18 years or > 74 years.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Plastic Surgery Unit, Umeå University hospital
Umeå
Rebecca Wiberg, MD, PhD, +4670-3884369, anna.rebecca.wiberg@gmail.com
About this study
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.
- Conditions
- Prophylactic Mastectomy
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of residual glandular tissue
Residual glandular tissue will be reported as being present or not present through postoperative evaluation with magnetic resonance tomography, ultrasound and mammography. The quadrants of the left and right breast will be examined after which the findings will be documented in pre-printed templates.
Measured: Residual glandular tissue will be evaluated 1 year postoperatively
Presence of residual glandular tissue
Residual glandular tissue will be reported as being present or not present through postoperative evaluation with magnetic resonance tomography, ultrasound and mammography. The quadrants of the left and right breast will be examined after which the findings will be documented in pre-printed templates.
Measured: Residual glandular tissue will be evaluated 3 years postoperatively
Measurement of skin flap thickness
The skin flap thickness will be evaluated postoperatively with magnetic resonance tomography, ultrasound and mammography. The quadrants of the left and right breast will be examined after which the findings will be documented in pre-printed templates. The skin flap thickness will be defined as the thickness of the skin (epidermis, dermis, subcutaneous tissue) measured at the examinations rather than the thickness of the skin flaps perioperatively. All measurements will be made in mm.
Measured: Skin flap thickness will be evaluated 1 year postoperatively
Measurement of skin flap thickness
The skin flap thickness will be evaluated postoperatively with magnetic resonance tomography, ultrasound and mammography. The quadrants of the left and right breast will be examined after which the findings will be documented in pre-printed templates. The skin flap thickness will be defined as the thickness of the skin (epidermis, dermis, subcutaneous tissue) measured at the examinations rather than the thickness of the skin flaps perioperatively. All measurements will be made in mm.
Measured: Skin flap thickness will be evaluated 3 years postoperatively
Secondary outcomes (5)
Change in evaluation of patient satisfaction
Patient satisfaction will be evaluated pre- and postoperatively with four different validated questionnaires; BREAST-Q, BRECON23, QLQ-C30 and Cancer-worry scale.
Measured: 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
Patient quality of life will be evaluated pre- and postoperatively with four different validated questionnaires; BREAST-Q, BRECON23, QLQ-C30 and Cancer-worry scale.
Measured: 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
Postoperative complications will be evaluated postoperatively by clinical examination and documented in pre-printed templates, and pictures will be taken. The complications will include breast related complications (skin flap necrosis, infection, hematoma, seroma and implant loss) and non-breast related complications (deep vein thrombosis, pulmonary embolism).
Measured: Clinical examination will be performed 2-4 weeks postoperatively.
Number of participants with long term postoperative complications
Postoperative complications will be evaluated postoperatively by clinical examination and documented in pre-printed templates, and pictures will be taken. The complications will include breast related complications (skin flap necrosis, infection, hematoma, seroma and implant loss) and non-breast related complications (deep vein thrombosis, pulmonary embolism).
Measured: Clinical examination will be performed 1 year postoperatively.
Number of participants with long term postoperative complications
Postoperative complications will be evaluated postoperatively by clinical examination and documented in pre-printed templates, and pictures will be taken. The complications will include breast related complications (skin flap necrosis, infection, hematoma, seroma and implant loss) and non-breast related complications (deep vein thrombosis, pulmonary embolism).
Measured: Clinical examination will be performed 3 years postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2021
- Study start25 Aug 2022
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Prophylactic MastectomyStudies of the same condition, open and under way.
- More trials run by Umeå UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rebecka Wiberg, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05162677
- Sponsor's protocol ID
- 2021-PrMa-RWiberg
- Status last verified
- May 2024
- First submitted
- 27 Oct 2021
- Last updated
- 8 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The study is currently a single center study but might in the future be expanded to a multicenter study. Furthermore, someone else with a different study question might want to use the cohort later on.
Publications
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.
PubMed 31907748Skoglund 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.
PubMed 34851154
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Mastectomy: Prospective Evaluation of the Correlation Between Skin Flap Thickness, Residual Glandular Tissue and Skin Necrosis by Imaging and Clinical Examination
- ClinicalTrials.gov ID
- NCT05162677
- Acronym / sponsor ID
- 2021-PrMa-RWiberg
- Conditions
- Prophylactic Mastectomy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Study start
- 25 Aug 2022 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 17 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 74 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Women undergoing mastectomy due to cancer.
- Age < 18 years or > 74 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Presence of residual glandular tissue
Time frame: Residual glandular tissue will be evaluated 1 year postoperatively
Residual glandular tissue will be reported as being present or not present through postoperative evaluation with magnetic resonance tomography, ultrasound and mammography. The quadrants of the left and right breast will be examined after which the findings will be documented in pre-printed templates.
Presence of residual glandular tissue
Time frame: Residual glandular tissue will be evaluated 3 years postoperatively
Residual glandular tissue will be reported as being present or not present through postoperative evaluation with magnetic resonance tomography, ultrasound and mammography. The quadrants of the left and right breast will be examined after which the findings will be documented in pre-printed templates.
Measurement of skin flap thickness
Time frame: Skin flap thickness will be evaluated 1 year postoperatively
The skin flap thickness will be evaluated postoperatively with magnetic resonance tomography, ultrasound and mammography. The quadrants of the left and right breast will be examined after which the findings will be documented in pre-printed templates. The skin flap thickness will be defined as the thickness of the skin (epidermis, dermis, subcutaneous tissue) measured at the examinations rather than the thickness of the skin flaps perioperatively. All measurements will be made in mm.
Measurement of skin flap thickness
Time frame: Skin flap thickness will be evaluated 3 years postoperatively
The skin flap thickness will be evaluated postoperatively with magnetic resonance tomography, ultrasound and mammography. The quadrants of the left and right breast will be examined after which the findings will be documented in pre-printed templates. The skin flap thickness will be defined as the thickness of the skin (epidermis, dermis, subcutaneous tissue) measured at the examinations rather than the thickness of the skin flaps perioperatively. All measurements will be made in mm.
5 secondary outcomes
Change in evaluation of patient satisfaction
Time frame: 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
Time frame: 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
Time frame: Clinical examination will be performed 2-4 weeks postoperatively.
Number of participants with long term postoperative complications
Time frame: Clinical examination will be performed 1 year postoperatively.
Number of participants with long term postoperative complications
Time frame: Clinical examination will be performed 3 years postoperatively.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Background: PubMed 31907748Wiberg 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.
- Background: PubMed 34851154Skoglund 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.
- Individual participant dataSharing planned: Undecided. The study is currently a single center study but might in the future be expanded to a multicenter study. Furthermore, someone else with a different study question might want to use the cohort later on.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prophylactic Mastectomy, run by Umeå University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rebecca Wiberg, MD PhD (+4690-785 0000, rebecka.wiberg@umu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of residual glandular tissue (time frame: Residual glandular tissue will be evaluated 1 year postoperatively). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05162677, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.