BC Risk Assessment Before Top Surgery

Medical College of Wisconsin

Status: Completed

Conditions: Breast Cancer; Risk Reduction

Treatments: Diagnostic Test: Breast Cancer Risk Assessment

Study type: Observational

Funder types: Other

Identifiers

NCT06239766

PRO00045830

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

25 participants in 1 patient group

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.

Treatment:

Diagnostic Test: Breast Cancer Risk Assessment