Clinical trial NCT06239766: BC Risk Assessment Before Top Surgery
Official title: Assessing Breast Cancer Risk Prior to Gender-Affirming Chest Masculinization Surgery in Transgender and Gender-Diverse Persons
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Risk Reduction
Keywords: Transgender
Gender Diverse
Nonbinary
Risk Assessment
Mastectomy
Top Surgery
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2024-02-02
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: TGD persons considering chest masculinization surgery.

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Estimated prevalence of TGD persons seeking chest masculinization surgery who at an elevated breast cancer risk.
timeFrame: 1 year
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
measure: Self-perceived breast cancer risk vs calculated breast cancer risk
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: The Medical College of Wisconsin
name: Chandler S Cortina
role: PRINCIPAL_INVESTIGATOR
References: