Multi-Institutional Transgender & Gender-Diverse Breast Cancer Study
A Multi-Institutional Retrospect Cohort Study of Breast Cancer Diagnosis and Management in Transgender and Gender-Diverse Individuals
A Multi-Institutional Retrospect Cohort Study of Breast Cancer Diagnosis and Management in Transgender and Gender-Diverse Individuals
Sponsor study identifier
observational
125
1 country
22
Study Start
December 8, 2023
Actual (reported)Primary Completion
November 1, 2024
Actual (reported)Study Completion
August 25, 2026
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 25, 2026
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 8, 2023
Actual (reported)January 23, 2024
Actual (reported)January 31, 2024
Actual (reported)November 1, 2024
Actual (reported)August 25, 2026
Actual (reported)Breast Cancer Diagnosis Method
Describe the method of breast cancer diagnosis (self detected vs screen detected vs healthcare provider detected) and compare to the published data from cisgender women by determining means and standard deviation and comparing rates using the Wilcoxon signed-rank test.
33 years
Breast Cancer Risk Factors
Assess breast cancer risk factors (family history, genetics, etc.), including a prior use of gender-affirming hormone therapy and/or gender-affirming surgery on tumor receptor status and stage at diagnosis using t-test and chi-squared test.
33 years
Breast Cancer Management Strategies
Report breast cancer management strategies (type of breast surgery, receipt of radiation, etc.) through descriptive and comparative staststics with a focus on the use of adjuvant endocrine therapy and gender-affirming hormone therapy for patients with hormone-receptor positive disease using t-test and chi-squared test.
Patients 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 their sex assigned at birth (e.g., transgender, nonbinary, genderqueer, etc.) between 1/1/1990 - 7/1/2023.
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.
University of Southern California/Los Angeles (USC/LA County)
Los Angeles, California, 90089, United States
University of California San Francisco (UCSF)
San Francisco, California, 94115, United States
University of Colorado Anschutz Medical Campus (CU Anschutz)
Aurora, Colorado, 80045, United States
MedStar Georgetown University Hospital (MGUH)
Washington D.C., District of Columbia, 20007, United States
Mayo Clinic
Jacksonville, Florida, 32224, United States
Moffitt Cancer Center (MCC)
Tampa, Florida, 33612, United States
Northwestern Medicine
Chandler S Cortina
The Medical College of Wisconsin
125 participants (actual enrollment reported by the registry).
First Submitted
January 23, 2024
First Posted
January 31, 2024
Study Start
December 8, 2023
Actual (reported)Study of the Safety of MRI Scans in People Who Have Breast Tissue Expanders After Mastectomy
33 years
Outcomes Data
Breast cancer local and distant recurrence, overall survival, and disease-free survival using Kaplan-Meier analysis. Cox Proportional Hazards model will be used to estimate the effect of various factors on distant metastasis-free and overall survival.
33 years
Contact the study team to confirm eligibility.
Chicago, Illinois, 60611, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
NorthShore University Health System
Evanston, Illinois, 60201, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Birgham and Women's Hospital
Boston, Massachusetts, 02115, United States
Boston University (Boston U)
Boston, Massachusetts, 02118, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
New York University (NYU)
New York, New York, 10012, United States
University of Rochester
Rochester, New York, 14623, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Cleveland Clinic Foundation (CCF)
Cleveland, Ohio, 44195, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
Vanderbilt University Medical Center (VUMC)
Nashville, Tennessee, 37232, United States
University of Washington (UW)
Seattle, Washington, 98195, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Primary Completion
November 1, 2024
Actual (reported)Study Completion
August 25, 2026
Actual (reported)Last Updated
August 27, 2026
Record last verified: 2026-01
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Source: ClinicalTrials.gov.
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