Using questionnaires and vaginal self-swabs to detect endometrial cancer risk
Official title: Non-Invasive Strategies for Early Detection of Uterine Cancer in Patients With Abnormal Uterine Bleeding
Run by University of British Columbia · NCT06268626 · Data updated 2026-11-12
This project will try questionnaires and vaginal self-swabs to see if they can predict endometrial cancer risk in people 40 and older who are having abnormal uterine bleeding and are referred for an endometrial biopsy.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 40 Years and up |
| Sex | Women only |
| Enrollment | 1000 (estimated) |
| Sponsor | University of British Columbia Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Vancouver, British Columbia) |
| Status | Recruiting |
| Started | October 10, 2024 |
| Main results expected | January 2027 |
| Study ends | January 2027 |
| Registry record updated | April 16, 2026 |
| Trial ID | NCT06268626 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are people age 40 or older with an intact uterus who have unexplained abnormal uterine bleeding and have been referred for an endometrial biopsy, with a subset invited for sequencing and longitudinal follow-up if they retain their uterus.
✕Probably not a fit
People with a recent endometrial sampling, pelvic radiation, recent vaginal infection, recent start of hormonal therapy, those already diagnosed with endometrial cancer or EIN, or those recommended for hysterectomy are unlikely to benefit from the non-invasive prediction goals of this project.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective case-cohort study will enroll over 1,000 people aged 40+ with unexplained abnormal uterine bleeding who are referred for endometrial biopsy. All participants complete an online health questionnaire and a subset will be invited to self-collect vaginal samples for DNA and microbiome sequencing and vaginal pH measurement. Selected participants with sequencing data will be followed longitudinally with repeat self-swabs, symptom questionnaires, and a wearable fitness tracker 6–8 months later to look for persistent mutations or microbiome changes. The study will combine questionnaire, clinical (including ultrasound and bleeding patterns), and biomarker data to build risk models that aim to improve prediction of endometrial cancer and its precursors.
Why it matters
Potential benefit: If successful, this approach could help identify people at higher risk of endometrial cancer earlier using non-invasive tests and better target who needs biopsy or closer follow-up.
How similar studies have gone: Early research using vaginal or uterine DNA and microbiome signatures has shown promising signals for detecting endometrial pathology, but the approach is still experimental and requires larger validation.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: Study Part A: * 40 years and older * Experiencing unexplained abnormal uterine bleeding (i.e., not from IUD, etc.) * Have an intact uterus * Referred for an endometrial biopsy Study Part B/Longitudinal monitoring: * Those selected for sequencing (from Part A) and who retained their uterus. Exclusion Criteria: Study Part A: * Endometrial sampling, pelvic radiation, or vaginal infection (vaginosis, yeast) in the past 3 months * Started hormone therapy (HRT, birth control, IUD) in the past year (with the exception of tamoxifen) * Intercourse, vaginal product use, or douching in the past 48 hours Study Part B/Longitudinal monitoring: * Same as Study Part A * EC or EIN, or anyone who is recommended a hysterectomy
Where it's running
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VGH Research Pavilion
Vancouver, British Columbia, Canada Recruiting
Study contacts
- Principal investigator: Aline Talhouk, PhD — University of British Columbia
- Study coordinator: Aline Talhouk, PhD
- Email: a.talhouk@ubc.ca
- Phone: +1 (604) 875-4111
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.