Using questionnaires and vaginal self-swabs to detect endometrial cancer risk
Non-Invasive Strategies for Early Detection of Uterine Cancer in Patients With Abnormal Uterine Bleeding
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 |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 40 Years and up |
| Sex | Female |
| Sponsor | University of British Columbia Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Vancouver, British Columbia) |
| Trial ID | NCT06268626 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Vancouver, British Columbia
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.