Cervical and Endometrial Cancer Screening in Patients Seeking Gender-Affirming Hysterectomy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Minnesota
About this trial
This study aims to quantify the rates of cervical cancer screening and endometrial sampling prior to gender-affirming hysterectomy, assess the need for these tests in TGD individuals, and explore patient-centered options for these tests. By assessing the status of testing and correlation with hysterectomy pathology, this study will provide preliminary data on the current state of guideline-concordant care and provide initial evidence for the development of evidence-based guidelines in the future
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Opted out of research
<18 years old
Lacks capacity to consent/has diminished capacity to consent
Cannot provide informed consent
Trial population
Patients who have undergone hysterectomy, or plan to have a hysterectomy. Patients who are transgender and gender diverse
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
No intervention
Other interventionObservational study
Treatment groups
40 Participants
are divided into 3 treatment groupsGroup A: Standard of Care Cancer Screening1 intervention
Group B: FDA approved self swab1 intervention
Group C: Mock self swab1 intervention
Trial outcomes
Primary outcomes
1
Rates of cervical cancer screening and endometrial sampling in TGD individuals
Describe the rates of cervical cancer screening and endometrial sampling in TGD individuals undergoing hysterectomy in the MHealth Fairview System between January 2014-June 2024.
Time frame
Month 362
Whether HPV self-testing affects the rates of cervical cancer screening in TGD individuals
Describe the rates of cervical and endometrial cancer and their precursor lesions on pathology after hysterectomy that was undiagnosed prior to hysterectomy in TGD individuals in the MHealth Fairview System between January 2014-June 2024.
Time frame
Month 36Secondary outcomes
1
how introducing the option of HPV self-testing affects the rates of cervical cancer screening in TGD individuals undergoing hysterectomy.
Assess how introducing the option of HPV self-testing affects the rates of cervical cancer screening in TGD individuals undergoing hysterectomy. Patients planning hysterectomy who are not up to date on cervical cancer screening will be offered standard cervical cancer screening or HPV self-testing. These participants will also be recruited to complete surveys and interviews. Patients who are up to date on cervical cancer screening prior to their hysterectomy consult will have the option to complete a mock self-swab or no testing. Participants who are up to date on cervical cancer screening will be surveyed regarding their experiences with cervical cancer screening and how the self-testing option impacts cervical cancer screening.
Time frame
Month 362
how introducing the option of HPV self-testing affects patient experience
Understand how introducing the option of non-invasive testing affects the patient experience for TGD patients undergoing hysterectomy. Recruited participants who are undergoing hysterectomy for gender-affirmation will be asked to complete surveys (N=30) and qualitative interviews (N=15) to evaluate how the option of self-testing or non-invasive testing affects the patient experience.
Time frame
Month 36Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov