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: Completed
• Conditions: Breast Cancer; Risk Reduction
• Intervention / Treatment: Diagnostic test: Breast Cancer Risk Assessment

• Study Type: Observational
• Enrollment (Actual): 25

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

TGD persons considering chest masculinization surgery.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Diagnostic test: Breast Cancer Risk Assessment; 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.	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

Collaborators and Investigators

• Sponsor: Medical College of Wisconsin
• Investigators: Principal Investigator: Chandler S Cortina, The Medical College of Wisconsin

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2023
• Primary Completion (Actual): December 29, 2023
• Study Completion (Actual): February 1, 2024

Study Registration Dates

• First Submitted: January 16, 2024
• First Submitted That Met QC Criteria: January 25, 2024
• First Posted (Actual): February 2, 2024

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 11, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Risk Assessment; Mastectomy; Transgender; Gender Diverse; Nonbinary; Top Surgery
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: PRO00045830

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No