Ignite Creation Date:
2025-12-24 @ 4:21 PM
Ignite Modification Date:
2025-12-26 @ 2:40 PM
Study NCT ID:
NCT06239766
Status:
COMPLETED
Last Update Posted:
2024-03-13
First Post:
2024-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BC Risk Assessment Before Top Surgery
Sponsor:
Medical College of Wisconsin
Organization:
Study Overview
Official Title:
Assessing Breast Cancer Risk Prior to Gender-Affirming Chest Masculinization Surgery in Transgender and Gender-Diverse Persons
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: