Multi-Institutional Transgender & Gender-Diverse Breast Cancer Study
- Conditions
- Breast Cancer StageBreast CancerBreast NeoplasmsBreast Cancer Stage IVBreast Cancer InvasiveBreast AdenocarcinomaBreast Cancer in Situ
- Registration Number
- NCT06234488
- Lead Sponsor
- Medical College of Wisconsin
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 125
- Age 18 years of age or older
- Breast cancer diagnosis (including DCIS)
- Persons who identify as gender and/or sex that is different from the sex they were assigned at birth
- Age <18 at time of breast cancer diagnosis
- Cis-gendered persons
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Breast Cancer Management Strategies 33 years 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.
Breast Cancer Risk Factors 33 years 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.
Outcomes Data 33 years 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.
Breast Cancer Diagnosis Method 33 years 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (21)
New York University (NYU)
🇺🇸New York, New York, United States
NorthShore University Health System
🇺🇸Evanston, Illinois, United States
Northwestern Medicine
🇺🇸Chicago, Illinois, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
University of Southern California/Los Angeles (USC/LA County)
🇺🇸Los Angeles, California, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Boston University (Boston U)
🇺🇸Boston, Massachusetts, United States
Cleveland Clinic Foundation (CCF)
🇺🇸Cleveland, Ohio, United States
University of Washington (UW)
🇺🇸Seattle, Washington, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
University of Rochester
🇺🇸Rochester, New York, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
University of California San Francisco (UCSF)
🇺🇸San Francisco, California, United States
Vanderbilt University Medical Center (VUMC)
🇺🇸Nashville, Tennessee, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
University of Colorado Anschutz Medical Campus (CU Anschutz)
🇺🇸Aurora, Colorado, United States
Moffitt Cancer Center (MCC)
🇺🇸Tampa, Florida, United States
Birgham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
MedStar Georgetown University Hospital (MGUH)
🇺🇸Washington, District of Columbia, United States
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States