A Multi-Institutional Retrospect Cohort Study of Breast Cancer Diagnosis and Management in Transgender and Gender-Diverse Individuals
Overview
- Phase
- Not Applicable
- Intervention
- Transgender and Gender-Diverse Persons with Breast Cancer
- Conditions
- Breast Cancer
- Sponsor
- Medical College of Wisconsin
- Enrollment
- 125
- Locations
- 39
- Primary Endpoint
- Breast Cancer Management Strategies
- Status
- Active, not recruiting
- Last Updated
- 3 months ago
Overview
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.
Investigators
Chandler S Cortina
Assistant Professor of Surgery
Medical College of Wisconsin
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •Age \<18 at time of breast cancer diagnosis
- •Cis-gendered persons
Arms & Interventions
Transgender and Gender-Diverse Persons with Breast Cancer
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.
Outcomes
Primary Outcomes
Breast Cancer Management Strategies
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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.