Cervical and endometrial cancer screening for people having gender-affirming hysterectomy
Cervical and Endometrial Cancer Screening in Patients Seeking Gender-Affirming Hysterectomy
This study will see how often transgender and gender-diverse adults get cervical cancer screening and endometrial sampling before a gender-affirming hysterectomy and whether those tests match what the hysterectomy finds.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Minnesota Academic / other |
| Locations | 1 site (Minneota, Minnesota) |
| Trial ID | NCT07075731 on ClinicalTrials.gov |
What this trial studies
This is an observational study enrolling transgender and gender-diverse adults who have had or plan to have a hysterectomy at the University of Minnesota. The study will collect information on prior cervical cancer screening (such as Pap tests) and any endometrial sampling, document adherence to current guideline-recommended testing, and compare preoperative test results with hysterectomy pathology when available. Researchers will also gather patient-centered preferences and options for how screening is offered. Results will provide preliminary data on current practice patterns and gaps to inform future evidence-based guidelines.
Who should consider this trial
Good fit: Adults aged 18 or older who are transgender or gender-diverse, have had or plan to have a hysterectomy, can read and speak English, and can give informed written consent.
Not a fit: People under 18, those unable to provide informed consent, those who opt out of research, or those not transgender or gender-diverse are not eligible and will not receive benefit from participating.
Why it matters
Potential benefit: If successful, the findings could help develop clearer screening guidance and reduce missed cervical or endometrial pathology in transgender and gender-diverse people undergoing hysterectomy.
How similar studies have performed: Prior research on cancer screening in transgender and gender-diverse populations exists but is limited, so this focused pre-hysterectomy screening work is relatively novel and builds on small observational studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 years and older * Able to provide voluntary written consent prior to the performance of any research related activity. Patients who can provide informed consent * Able to understand, speak, read, and write in English * Patients who have undergone hysterectomy, or plan to have a hysterectomy * Patients who are transgender and gender diverse" Exclusion Criteria: * Opted out of research * \<18 years old * Lacks capacity to consent/has diminished capacity to consent * Cannot provide informed consent * Those on the study's community advisory board
Where this trial is running
Minneota, Minnesota
- University of Minnesota — Minneota, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Meredith Wise — University of Minnesota
- Study coordinator: Maria Bunch
- Email: obgynresearch@umn.edu
- Phone: 612-624-2018
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.