Cancer ScreeningNCT07075731
Cervical and Endometrial Cancer Screening in Patients Seeking Gender-Affirming Hysterectomy
An observational study of Cancer Screening and Transgender, run by University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Screening, Transgender, Gender Diverse Populations
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2025to 30 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients who have undergone hysterectomy, or plan to have a hysterectomy. Patients who are transgender and gender diverse
Who may be able to join
- 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"
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Minnesota
Minneota, Minnesota, 55455
Samantha Hoffman, MD, 612-273-7117, kehoe018@umn.edu
About this study
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
- Being tested
- No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
Observational study
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care Cancer Screening | Not described Receives: Other: No intervention | |
| FDA approved self swab | Not described Receives: Other: No intervention | |
| Mock self swab | Not described Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
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.
Measured: Month 36
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.
Measured: Month 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study start30 Jun 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer ScreeningStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samantha Hoffman, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07075731
- Sponsor's protocol ID
- 2023LS213
- Status last verified
- Jul 2026
- First submitted
- 10 Jul 2025
- Last updated
- 16 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cervical and Endometrial Cancer Screening in Patients Seeking Gender-Affirming Hysterectomy
- ClinicalTrials.gov ID
- NCT07075731
- Acronym / sponsor ID
- 2023LS213
- Conditions
- Cancer Screening, Transgender, Gender Diverse Populations
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 30 Jun 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 20 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard of Care Cancer Screening | – | Other: No intervention |
| FDA approved self swab | – | Other: No intervention |
| Mock self swab | – | Other: No intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients who have undergone hysterectomy, or plan to have a hysterectomy. Patients who are transgender and gender diverse
Key inclusion criteria (5 listed)
- 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"
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionObservational study | Other | FDA approved self swab, Mock self swab, Standard of Care Cancer Screening |
Primary outcome
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.
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.
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Samantha Hoffman, MD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer Screening and Transgender, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Samantha Hoffman, MD ((612)273-7117, kehoe018@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rates of cervical cancer screening and endometrial sampling in TGD individuals (time frame: Month 36). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.