Cervical and Endometrial Cancer Screening in Patients Seeking Gender-Affirming Hysterectomy

NCT07075731 | Recruiting

• 1 other identifier: 2023LS213
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cancer Screening; Transgender; Gender Diverse Populations

Outcome Measures

Primary Outcomes (2)

• 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.

  Month 36

• 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.

  Month 36

Secondary Outcomes (2)

• how introducing the option of HPV self-testing affects the rates of cervical cancer screening in TGD individuals undergoing hysterectomy.

  Month 36

• how introducing the option of HPV self-testing affects patient experience

  Month 36

Study Arms (3)

Standard of Care Cancer Screening

Other: No intervention

FDA approved self swab

Other: No intervention

Mock self swab

Other: No intervention

Interventions

No intervention OTHER

Observational study

FDA approved self swab; Mock self swab; Standard of Care Cancer Screening

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who have undergone hysterectomy, or plan to have a hysterectomy. Patients who are transgender and gender diverse

You may qualify if:

• 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"

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneota, Minnesota, 55455, United States

RECRUITING

Study Officials

• Meredith Wise

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Bunch

CONTACT

612-624-2018; obgynresearch@umn.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2025
• First Posted: July 20, 2025
• Study Start: June 30, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: July 20, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)