Clinical trial NCT06234488: Multi-Institutional Transgender & Gender-Diverse Breast Cancer Study
Official title: A Multi-Institutional Retrospect Cohort Study of Breast Cancer Diagnosis and Management in Transgender and Gender-Diverse Individuals
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Breast Cancer
Breast Neoplasms
Breast Adenocarcinoma
Breast Cancer Stage
Breast Cancer Stage IV
Breast Cancer Invasive
Breast Cancer in Situ
Keywords: Transgender
Breast Cancer
Nonbinary
Gender Diverse
Gender-Affirming Hormone Therapy
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2024-01-31
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible patients are those who had a breast cancer diagnosis (including those with ductal carcinoma in situ (DCIS), who were age ≥18 years at the time of diagnosis and identify as a gender and/or sex that is different from the sex they were assigned at birth (e.g., transgender, nonbinary, genderqueer, etc.) between 1/1/1990 - 7/1/2023.

Brief summary: There is no granular retrospective data on breast cancer in transgender and gender-diverse (TGD) persons from a contemporary and diverse American cohort. The purpose of this investigation is to aggregate data from multiple institutions to describe the risk, diagnosis, management, and outcomes of TGD persons with breast cancer in effort to identify opportunities for future intervention studies to eliminate breast cancer disparities for this population.


Eligibility criteria: Inclusion Criteria:

1. Age 18 years of age or older
2. Breast cancer diagnosis (including DCIS)
3. Persons who identify as gender and/or sex that is different from the sex they were assigned at birth

Exclusion Criteria:

1. Age \<18 at time of breast cancer diagnosis
2. Cis-gendered persons

Primary outcomes:
measure: Breast Cancer Diagnosis Method
timeFrame: 33 years
measure: Breast Cancer Risk Factors
timeFrame: 33 years
measure: Breast Cancer Management Strategies
timeFrame: 33 years
measure: Outcomes Data
timeFrame: 33 years
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California/Los Angeles (USC/LA County)
state: California
city: San Francisco
country: United States
facility: University of California San Francisco (UCSF)
state: California
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus (CU Anschutz)
state: Colorado
city: Washington
country: United States
facility: MedStar Georgetown University Hospital (MGUH)
state: District of Columbia
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
city: Tampa
country: United States
facility: Moffitt Cancer Center (MCC)
state: Florida
city: Chicago
country: United States
facility: Northwestern Medicine
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Evanston
country: United States
facility: NorthShore University Health System
state: Illinois
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Birgham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Boston University (Boston U)
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: New York
country: United States
facility: New York University (NYU)
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation (CCF)
state: Ohio
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center (VUMC)
state: Tennessee
city: Seattle
country: United States
facility: University of Washington (UW)
state: Washington
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: The Medical College of Wisconsin
name: Chandler S Cortina
role: PRINCIPAL_INVESTIGATOR
References: