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NCT Number: NCT07075731

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

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

Recruiting

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Key information

Conditions

Cancer Screening Gender Diverse Populations Transgender

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Minnesota

Minneota, Minnesota, 55455, United States

Location status: Recruiting

Location contact

Samantha Hoffman, MD

CONTACT

[email protected]

612-273-7117

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

Observational study

Primary outcomes

  1. Rates of cervical cancer screening and endometrial sampling in TGD individuals

    Time frame: Month 36

    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.

  2. Whether HPV self-testing affects the rates of cervical cancer screening in TGD individuals

    Time frame: Month 36

    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.

Secondary outcomes

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

    Time frame: Month 36

    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.

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

    Time frame: Month 36

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Samantha Hoffman, MD

CONTACT

[email protected]

(612)273-7117

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 20, 2025
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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