BC Risk Assessment Before Top Surgery

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.

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Key information

Conditions

Breast Cancer Behavior Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Risk Reduction Risk Reduction Behavior Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Breast Cancer Risk Assessment

Diagnostic Test

Gail and IBIS Tools will be utilized to calculate mean lifetime breast cancer risk

Primary outcomes

Estimated prevalence of TGD persons seeking chest masculinization surgery who at an elevated breast cancer risk.

Time frame: 1 year

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.
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.
Self-perceived breast cancer risk vs calculated breast cancer risk

Time frame: 1 year

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.

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Registry information

Official study title

Assessing Breast Cancer Risk Prior to Gender-Affirming Chest Masculinization Surgery in Transgender and Gender-Diverse Persons

Important dates

Study start: 2023
Primary completion: 2023
Study completion: 2024
First posted: Feb 2, 2024
Registry last updated: Mar 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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