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

NCT ID: NCT07075731

Last Updated: 2025-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-06-30

Study Completion Date

2027-06-30

Brief Summary

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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

Detailed Description

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Conditions

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Cancer Screening Transgender Gender Diverse Populations

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Standard of Care Cancer Screening

No intervention

Intervention Type OTHER

Observational study

FDA approved self swab

No intervention

Intervention Type OTHER

Observational study

Mock self swab

No intervention

Intervention Type OTHER

Observational study

Interventions

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No intervention

Observational study

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Meredith Wise

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

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University of Minnesota

Minneota, Minnesota, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Maria Bunch

Role: CONTACT

612-624-2018

Facility Contacts

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Maria Bunch

Role: primary

612-624-2018

Other Identifiers

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2023LS213

Identifier Type: -

Identifier Source: org_study_id

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