Clinical trial · Observational
BC Risk Assessment Before Top Surgery
Assessing Breast Cancer Risk Prior to Gender-Affirming Chest Masculinization Surgery in Transgender and Gender-Diverse Persons
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Risk Reduction | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Breast Cancer Risk Assessment | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Non-Cisgender Adults Considering Chest Masculinization Surgery
- description
- Persons assigned female or intersex at birth who identify as TGD and are considering gender-affirming chest masculinization surgery.
- interventionNames
- Diagnostic Test: Breast Cancer Risk Assessment
Primary outcomes (3)
- measure
- Estimated prevalence of TGD persons seeking chest masculinization surgery who at an elevated breast cancer risk.
- timeFrame
- 1 year
- description
- 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.
- measure
- 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.
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. ≥18 years old. 2. Assigned female or intersex at birth and identify as non-cisgender. 3. Any individual considering undergoing gender-affirming chest masculinization surgery 4. Ability to communicate in English. 5. Ability to understand a written informed consent document, and the willingness to sign it. Exclusion Criteria: 1. \<18 years old. 2. Assigned male sex at birth. 3. Previously underwent chest masculinization surgery or any form of oncological mastectomy for the purposes of risk-reduction or cancer treatment. 4. Any previous or current history of breast cancer, including ductal carcina in situ (DCIS). 5. Inability to communicate in English.
References
Publications (2)
- DERIVEDCortina 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. PMID 39060689
- DERIVEDCortina 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. PMID 38940898