The study goal is to investigate a non-invasive approach to predict endometrial cancer (EC) risk, better understand disease progression and identify opportunities for intervention.
This two-part case-cohort prospective study will recruit patients whose abnormal uterine bleeding is being evaluated via endometrial biopsy. Participants will complete an online health questionnaire, and a subset will be invited to self-collect vaginal samples for sequencing.
Selected sequenced participants will be invited for longitudinal monitoring (questionnaires, wearable fitness tracker) and an additional vaginal self-collection to identify persistent genetic mutations or microbiome alterations 6-8 months later.
Eligibility
Sex
FEMALE
Min age
40 Years
Max age
—
Healthy volunteers
Accepted
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
Primary outcome measure(s)
Diagnostic Performance of cfDNA Mutation Detection for Endometrial Pathology — Through study completion, anticipated 1-2 years Cell-free DNA (cfDNA) extracted from vaginal swabs will be sequenced to identify endometrial cancer-associated mutations. Diagnostic performance will be evaluated by calculating sensitivity, specificity, accuracy, positive predictive value, and negative predictive value for detecting endometrial pathology, using biopsy-confirmed pathology as the reference standard.
Association Between Vaginal Microbiome Profile and Endometrial Pathology — Through study completion, anticipated 1-2 years Vaginal microbiome DNA extracted from swabs will be sequenced and processed into operational taxonomic units (OTUs) using an in-house bioinformatics pipeline. OTUs will be compared across biopsy-confirmed pathology groups and evaluated against previously published microbiome signatures predictive of endometrial cancer.
Trial sites (1)
Facility
City
Region
Status
VGH Research Pavilion
Vancouver
British Columbia
Recruiting
More University of British Columbia trials in Canada
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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