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The population of transgender and gender-diverse (TGD) persons in Wisconsin and the U.S. is steadily increasing. As this population grows, the number of individuals seeking gender-affirming therapies, including gender-affirming operations and gender-affirming hormone therapy, is also growing. An example of gender-affirming surgery is chest masculinization surgery, in which most breast tissue is removed in a person assigned female or intersex at birth to allow the chest to appear masculine. Gender-affirming chest masculinization surgery is not generally considered equivalent to an oncologic mastectomy, which aims to removal all breast tissue for future breast cancer reduction or current breast cancer treatment.
The goals of this investigation are to 1) determine the percent of TGD persons considering chest masculinization surgery who have an elevated lifetime risk of breast cancer development and/or a pathogenic genetic mutation; 2) measure the percent who are at risk and choose to undergo risk-reducing mastectomies as part of chest masculinization surgery; and 3) assess and compare self-perceived breast cancer risk with calculated risk.
The results of this study will substantially inform TGD patients and surgeons on the utility of personalized breast cancer risk assessment prior to chest masculinization surgery and the accuracy of self-perceived breast cancer risk in TGD persons.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-Cisgender Adults Considering Chest Masculinization Surgery | Persons assigned female or intersex at birth who identify as TGD and are considering gender-affirming chest masculinization surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Breast Cancer Risk Assessment | Diagnostic Test | Gail and IBIS Tools will be utilized to calculate mean lifetime breast cancer risk |
|
| Measure | Description | Time Frame |
|---|---|---|
| Estimated prevalence of TGD persons seeking chest masculinization surgery who at an elevated breast cancer risk. | Validated breast cancer risk calculators (IBIS and Gail) will be used to determine lifetime breast cancer risk of participants enrolled into the study. Ranges and 95% CI will be made to estimate the percent of TGD persons at risk. | 1 year |
| Rate of uptake of oncologic risk reducing mastectomies as part of chest masculinization surgery in TGD persons at risk of breast cancer based on validated models. | To determine whether those TGD persons at elevated risk of breast cancer development choose to undergo risk-reducing mastectomies as part of their chest masculinization surgery. | 1 year |
| Self-perceived breast cancer risk vs calculated breast cancer risk | A visual analog scale from 0-100% will be used to compare and assess the self-perceived estimated breast cancer risk with calculated breast cancer risk. 13% is marked as the average cisgender women's risk of breast cancer and participants report their self-perceived risk as single whole integer (ex. 8%, 15%, 25%, etc.) on the scale from 0-100% where 0-12% represents below average risk person and 13-100% represent above average risk. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
Persons who identify as transgender, nonbinary, and/or gender-diverse (TGD) who were assigned female and/or intersex at birth.
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TGD persons considering chest masculinization surgery.
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| Name | Affiliation | Role |
|---|---|---|
| Chandler S Cortina | The Medical College of Wisconsin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39060689 | Derived | Cortina CS. ASO Author Reflections: A Breast Cancer Risk Assessment and the Decision for Gender-Affirming Chest Masculinization Surgery or Oncologic Risk-Reducing Mastectomies in Transgender and Gender-Diverse Individuals. Ann Surg Oncol. 2024 Oct;31(11):7483-7484. doi: 10.1245/s10434-024-15801-z. Epub 2024 Jul 26. No abstract available. | |
| 38940898 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 30, 2023 | Jan 16, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 20, 2023 | Jan 16, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D040242 | Risk Reduction Behavior |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Cortina CS, Purdy A, Brazauskas R, Stachowiak SM, Fodrocy J, Klement KA, Sasor SE, Krucoff KB, Robertson K, Buth J, Lakatos AEB, Petroll AE, Doren EL. The Impact of a Breast Cancer Risk Assessment on the Decision for Gender-Affirming Chest Masculinization Surgery in Transgender and Gender-Diverse Individuals: A Pilot Single-Arm Educational Intervention Trial. Ann Surg Oncol. 2024 Oct;31(11):7474-7482. doi: 10.1245/s10434-024-15701-2. Epub 2024 Jun 28. |
| D017437 |
| Skin and Connective Tissue Diseases |
| D001519 | Behavior |