Clinical trial NCT06383026: Transgender and Gender-Diverse Breast Cancer Screening Pilot
Official title: Understanding Breast Cancer Risk and Screening in Transgender and Gender-Diverse Persons Through a Pilot Breast Cancer Screening Program
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Breast Cancer
Keywords: Transgender
Gender Diverse
Nonbinary
Mammogram
Mammography
Breast Cancer Screening
Breast Ultrasound
Breast Ultrasonography
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2024-04-25
Enrollment: 130
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: TGD persons and breast cancer radiology stakeholders.

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Callback and Biopsy Rates after Breast Cancer Screening
timeFrame: 3.5 years
measure: Reflexive Thematic Analysis of the Physical, Cognitive, and Emotional Experience of Breast Cancer Screening in Transgender and Gender Diverse Persons
timeFrame: 3.5 years
measure: Reflexive Thematic Analysis on the Individual & System-Level Barriers to Breast Cancer Screening
timeFrame: 3.5 years
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, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: