BC Risk Assessment Before Top Surgery
Assessing Breast Cancer Risk Prior to Gender-Affirming Chest Masculinization Surgery in Transgender and Gender-Diverse Persons
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Wisconsin
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Milwaukee, Wisconsin, United States, 53226
- Medical College of Wisconsin
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- ≥18 years old.
- Assigned female or intersex at birth and identify as non-cisgender.
- Any individual considering undergoing gender-affirming chest masculinization surgery
- Ability to communicate in English.
- Ability to understand a written informed consent document, and the willingness to sign it.
Exclusion Criteria:
- <18 years old.
- Assigned male sex at birth.
- Previously underwent chest masculinization surgery or any form of oncological mastectomy for the purposes of risk-reduction or cancer treatment.
- Any previous or current history of breast cancer, including ductal carcina in situ (DCIS).
- Inability to communicate in English.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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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.
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Gail and IBIS Tools will be utilized to calculate mean lifetime breast cancer risk
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Estimated prevalence of TGD persons seeking chest masculinization surgery who at an elevated breast cancer risk.
Time Frame: 1 year
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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.
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1 year
|
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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.
Time Frame: 1 year
|
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.
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1 year
|
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Self-perceived breast cancer risk vs calculated breast cancer risk
Time Frame: 1 year
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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.
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1 year
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Chandler S Cortina, The Medical College of Wisconsin
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRO00045830
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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