Transgender and Gender-Diverse Breast Cancer Screening Pilot

Breast Cancer Clinical Trial

Official title:

Understanding Breast Cancer Risk and Screening in Transgender and Gender-Diverse Persons Through a Pilot Breast Cancer Screening Program

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06383026
• Other study ID #: PRO00047199
• Status: Recruiting
• Start date: April 17, 2024
• Est. completion date: February 2028

Study information

• Verified date: April 2024
• Source: Medical College of Wisconsin
• Contact: Chandler S Cortina, MD, MS
• Phone: 4149551453
• Email: ccortina[@]mcw.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This investigation is a prospective breast cancer screening study open to all transgender and gender-diverse persons (regardless of sex assigned at birth). Using a mixed methods approach, the study will 1) gather prospective quantitative breast imaging data in conjunction with gender-affirming therapy and family cancer history and 2) investigate TGD persons perceptions and experiences in the breast cancer screening program, and 3) identify individual and systems-level barriers to breast cancer screening.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: February 2028
• Est. primary completion date: December 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years and older

Eligibility

Inclusion Criteria for Transfeminine/Nonbinary/Gender-Diverse Persons:

1. Assigned male or intersex at birth and do not identify as cisgender

2. Age:

1. 40-75 years

2. 35-39 years with a family history of breast cancer, defined as =1 1st or 2nd degree relative(s) with a breast cancer diagnosis

3. 30-34 with a 1st degree relative with a breast cancer diagnosis age =45

3. A history of gender-affirming hormone therapy =9 months.

4. Ability to speak, read, and write in English.

5. Ability to understand a written informed consent document, and the willingness to sign it.

Inclusion Criteria for Transmasculine/Nonbinary/Gender-Diverse Persons:

1. Assigned female or intersex at birth and do not identify as cisgender

2. Age:

1. 40-75 years

2. 35-39 years with a family history of breast cancer, defined as =1 1st or 2nd degree relative(s) with a breast cancer diagnosis

3. 30-34 years with a 1st degree relative with a breast cancer diagnosis age =45

3. Any history of gender-affirming hormone therapy, regardless of duration.

4. Has not undergone a complete mastectomy for oncologic or risk-reducing reasons. (Note:

those who have undergone top surgery are eligible, assuming they meet this criterion).

5. Ability to speak, read, and write in English.

6. Ability to understand a written informed consent document, and the willingness to sign it.

Inclusion Criteria for Breast Radiology Faculty:

1. Board-certified radiologist that specializes in breast imaging and are an actively employed faculty member at Froedtert & the Medical College of Wisconsin (main campus location).

2. Part of the breast radiology faculty who read both ABUS and MMG of the TGD study participants.

3. Ability to speak, read, and write in English.

4. Ability to understand a written informed consent document, and the willingness to sign it.

Inclusion Criteria for Breast Radiology Staff:

1. Must be either a technician, nurse, or clerical staff that works with the breast radiology team at Froedtert & the Medical College of Wisconsin (main campus location).

2. Ability to understand a written informed consent document, and the willingness to sign it.

3. Ability to speak, read, and write in English.

Exclusion Criteria for Transfeminine/Nonbinary/Gender-Diverse Persons

1. Has a history of breast cancer.

2. Has a known pathogenic gene mutation that increases the risk of breast cancer development (e.g., BRCA1/2).

3. Has not been on GAHT for = 9 months.

Exclusion Criteria for Transmasculine/Nonbinary/Gender-Diverse Persons

1. Has undergone or planned to undergo a complete mastectomy.

2. Has a history of breast cancer.

3. Has a known pathogenic gene mutation that increases the risk of breast cancer development (e.g., BRCA1/2).

Exclusion Criteria for Breast Radiology Faculty

1. Not a board-certified radiologist.

2. Does not specialize in breast imaging.

3. Does not read ABUS and MMG and/or has not read imaging for study participants.

Exclusion for Breast Radiology Staff

1. Does not work with the breast radiology team.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Diagnostic Test:
• Breast Cancer Screening
Screening mammography as well as whole breast ultrasound interpreted by BI-RADS.

Other:
• Survey/Interview
A mixed-methods approach including electronic surveys and one on one interviews.
• Focus Group
A semi-structured focus group with open-ended questions that explores faculty and staff experiences in a breast cancer screening program for transgendered and nonbinary persons.

Locations

Country	Name	City	State
United States	Medical College of Wisconsin	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Medical College of Wisconsin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Callback and Biopsy Rates after Breast Cancer Screening	Determine the callback and biopsy rates after screening imaging of the entire TGD patient cohort who complete breast imaging exams.	3.5 years
Primary	Reflexive Thematic Analysis of the Physical, Cognitive, and Emotional Experience of Breast Cancer Screening in Transgender and Gender Diverse Persons	Qualitative data utilized to identify themes around health beliefs, anxiety, and the breast cancer screening experience by describing the physical, cognitive, and emotional experience (perceived seriousness, perceived susceptibility, and anxiety) of TGD cohort participants who complete surveys or participate in one-on-one interviews.	3.5 years
Primary	Reflexive Thematic Analysis on the Individual & System-Level Barriers to Breast Cancer Screening	Qualitative date utilized to identify individual and healthcare systems-level barriers to breast cancer screening for transgender persons who complete surveys and/or participate in one-on-one interviews and breast imaging faculty and staff who participate in focus groups.	3.5 years