NCT06239766|Completed
BC Risk Assessment Before Top Surgery
Assessing Breast Cancer Risk Prior to Gender-Affirming Chest Masculinization Surgery in Transgender and Gender-Diverse Persons
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Assessing Breast Cancer Risk Prior to Gender-Affirming Chest Masculinization Surgery in Transgender and Gender-Diverse Persons
Sponsor study identifier
observational
25
1 country
1
Study Start
March 15, 2023
Actual (reported)Primary Completion
December 29, 2023
Actual (reported)Study Completion
February 1, 2024
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 1, 2024
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 15, 2023
Actual (reported)December 29, 2023
Actual (reported)January 16, 2024
Actual (reported)February 1, 2024
Actual (reported)February 2, 2024
Actual (reported)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
Persons assigned female or intersex at birth who identify as TGD and are considering gender-affirming chest masculinization surgery.
Gail and IBIS Tools will be utilized to calculate mean lifetime breast cancer risk
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
TGD persons considering chest masculinization surgery.
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Cortina CS. ASO Author Reflections: A Breast Cancer Risk Assessment and the Decision for Gender-Affirming Chest Masculinization Surgery or Oncologic Risk-Reducing Mastectomies in Transgender and Gender-Diverse Individuals. Ann Surg Oncol. 2024 Oct;31(11):7483-7484. doi: 10.1245/s10434-024-15801-z. Epub 2024 Jul 26. No abstract available.
Cortina CS, Purdy A, Brazauskas R, Stachowiak SM, Fodrocy J, Klement KA, Sasor SE, Krucoff KB, Robertson K, Buth J, Lakatos AEB, Petroll AE, Doren EL. The Impact of a Breast Cancer Risk Assessment on the Decision for Gender-Affirming Chest Masculinization Surgery in Transgender and Gender-Diverse Individuals: A Pilot Single-Arm Educational Intervention Trial. Ann Surg Oncol. 2024 Oct;31(11):7474-7482. doi: 10.1245/s10434-024-15701-2. Epub 2024 Jun 28.
Chandler S Cortina
The Medical College of Wisconsin
25 participants (actual enrollment reported by the registry).
First Submitted
January 16, 2024
First Posted
February 2, 2024
Study Start
March 15, 2023
Actual (reported)Understanding and Addressing Disparities in Cancer Therapy Induced Inflammation and Associated Endothelial Dysfunction
Contact the study team to confirm eligibility.
Primary Completion
December 29, 2023
Actual (reported)Study Completion
February 1, 2024
Actual (reported)Last Updated
March 13, 2024
Record last verified: 2024-03
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Source: ClinicalTrials.gov.
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