Breast Cancer Clinical Trial
Official title:
A Multi-Institutional Retrospect Cohort Study of Breast Cancer Diagnosis and Management in Transgender and Gender-Diverse Individuals
| Verified date | June 2024 |
| Source | Medical College of Wisconsin |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Active, not recruiting |
| Enrollment | 125 |
| Est. completion date | December 30, 2025 |
| Est. primary completion date | August 1, 2025 |
| Accepts healthy volunteers | |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Michigan | Ann Arbor | Michigan |
| United States | University of Colorado Anschutz Medical Campus (CU Anschutz) | Aurora | Colorado |
| United States | Boston University (Boston U) | Boston | Massachusetts |
| United States | Northwestern Medicine | Chicago | Illinois |
| United States | Rush University Medical Center | Chicago | Illinois |
| United States | University of Cincinnati (UC) | Cincinnati | Ohio |
| United States | Cleveland Clinic Foundation (CCF) | Cleveland | Ohio |
| United States | Duke University Medical Center | Durham | North Carolina |
| United States | NorthShore University Health System | Evanston | Illinois |
| United States | Mayo Clinic | Jacksonville | Florida |
| United States | University of Southern California/Los Angeles (USC/LA County) | Los Angeles | California |
| United States | Medical College of Wisconsin | Milwaukee | Wisconsin |
| United States | Vanderbilt University Medical Center (VUMC) | Nashville | Tennessee |
| United States | New York University (NYU) | New York | New York |
| United States | Fox Chase Cancer Center | Philadelphia | Pennsylvania |
| United States | Mayo Clinic | Rochester | Minnesota |
| United States | University of Rochester | Rochester | New York |
| United States | University of California San Francisco (UCSF) | San Francisco | California |
| United States | University of Washington (UW) | Seattle | Washington |
| United States | Moffitt Cancer Center (MCC) | Tampa | Florida |
| United States | MedStar Georgetown University Hospital (MGUH) | Washington | District of Columbia |
| Lead Sponsor | Collaborator |
|---|---|
| Medical College of Wisconsin |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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. | 33 years | |
| Primary | 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 |
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