Endometrial CarcinomaNCT07527143
Acceptability of Testing DNA Markers in Vaginal Fluid for the Detection of Endometrial Cancer
An observational study of Endometrial Carcinoma, run by Mayo Clinic at 1 site in United States.
Trial summary
This study evaluates how women feel about using DNA from a vaginal fluid collection for early detection of endometrial cancer. Read more about this study
- Who is it for?
- Ages 45 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometrial Carcinoma
- What is being tested?
- Non-Interventional Study
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jun 2026to 10 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 45 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Self-identified Black females 45 years or older with an intact uterus recruited through Mayo Clinic in Rochester
Who may be able to join
- Self-identified Black individuals ≥ 45 years with an intact uterus
- Assigned female sex at birth
- Experience with abnormal uterine or post-menopausal bleeding (defined as vaginal bleeding between periods, heavy vaginal bleeding, vaginal bleeding after menopause, and/or red, brown, or pink colored vaginal discharge after menopause)
- Willing to participate in a 45-minute virtual interview
Who cannot join
- Previous or current diagnosis of endometrial cancer
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kelly Gunderson contact
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Clinical Trials Referral Office, 855-776-0015
Kelly Gunderson, 507-422-1892
About this study
This study evaluates how women feel about using DNA from a vaginal fluid collection for early detection of endometrial cancer.
- Conditions
- Endometrial Carcinoma
- Being tested
- Non-Interventional Study
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Interventional StudyOther
Also called Non-Interventional Observational Study, Noninterventional (Observational) Study
Non-interventional study
| Study group | Role | What they receive |
|---|---|---|
| Observational | Participants complete a semi-structured interview on study. Receives: Other: Non-Interventional Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of vaginal fluid collection for a DNA-based early detection endometrial cancer test
Information collected during a 30-minute virtual interview using mostly open-ended questions. The interviews will be transcribed and reviewed by the study team to identity themes and create coding categories. Coding categories will be used to organize the data into subthemes. Results will be reported in aggregate. Aggregate results will be disseminated to participants if they elect to receive them.
Measured: Baseline (30-minute virtual interview)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start10 Jun 2026
- Primary completion10 Jun 2027 (estimated)
- Study completion10 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CarcinomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shariska Harrington, Mayo Clinic
- Investigators
- Shariska Harrington, MD, Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07527143
- Sponsor's protocol ID
- 25-011120
- Status last verified
- Jul 2026
- First submitted
- 7 Apr 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- 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 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability of Testing DNA Markers in Vaginal Fluid for the Detection of Endometrial Cancer
- ClinicalTrials.gov ID
- NCT07527143
- Acronym / sponsor ID
- 25-011120
- Conditions
- Endometrial Carcinoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 10 Jun 2026 (actual)
- Primary completion
- 10 Jun 2027 (estimated)
- Study completion
- 10 Jun 2027 (estimated)
- First posted
- 14 Apr 2026 (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 evaluates how women feel about using DNA from a vaginal fluid collection for early detection of endometrial cancer.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational | – | Other: Non-Interventional StudyParticipants complete a semi-structured interview on study. |
Who may qualify
- Ages
- 45 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Self-identified Black females 45 years or older with an intact uterus recruited through Mayo Clinic in Rochester
Key inclusion criteria (4 listed)
- Self-identified Black individuals ≥ 45 years with an intact uterus
- Assigned female sex at birth
- Experience with abnormal uterine or post-menopausal bleeding (defined as vaginal bleeding between periods, heavy vaginal bleeding, vaginal bleeding after menopause, and/or red, brown, or pink colored vaginal discharge after menopause)
- Willing to participate in a 45-minute virtual interview
Key exclusion criteria (1 listed)
- Previous or current diagnosis of endometrial cancer
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 |
|---|---|---|
| Non-Interventional StudyAlso: Non-Interventional Observational Study, Noninterventional (Observational) StudyNon-interventional study | Other | Observational |
Primary outcome
Acceptability of vaginal fluid collection for a DNA-based early detection endometrial cancer test
Time frame: Baseline (30-minute virtual interview)
Information collected during a 30-minute virtual interview using mostly open-ended questions. The interviews will be transcribed and reviewed by the study team to identity themes and create coding categories. Coding categories will be used to organize the data into subthemes. Results will be reported in aggregate. Aggregate results will be disseminated to participants if they elect to receive them.
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 9 Jul 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- 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.
Kelly Gunderson contact
Shariska Harrington, MD principal investigator
Mayo Clinic in Rochester
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 Endometrial Carcinoma, run by Mayo Clinic 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 4 inclusion and 1 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 9 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 Clinical Trials Referral Office (855-776-0015, mayocliniccancerstudies@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of vaginal fluid collection for a DNA-based early detection endometrial cancer test (time frame: Baseline (30-minute virtual interview)). 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 9 Jul 2026.