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Recruiting NCT07075731

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

Observational Cancer Screening Transgender Gender Diverse Populations

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: No intervention.
Who it may be relevant to
Registry conditions: Cancer Screening, Transgender, Gender Diverse Populations. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

Interventions

  • Other No intervention
    Observational study

Primary outcome measures

  • Rates of cervical cancer screening and endometrial sampling in TGD individuals [Time frame: Month 36]
  • Whether HPV self-testing affects the rates of cervical cancer screening in TGD individuals [Time frame: Month 36]
Secondary outcome measures (2)
  • how introducing the option of HPV self-testing affects the rates of cervical cancer screening in TGD individuals undergoing hysterectomy. [Time frame: Month 36]
  • how introducing the option of HPV self-testing affects patient experience [Time frame: Month 36]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • University of Minnesota — Minneota

Identifiers

NCT: NCT07075731 · 2023LS213

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗