Detection of Endometrial Cancer Through Risk Modelling
DETECTR
Non-Invasive Strategies for Early Detection of Uterine Cancer in Patients With Abnormal Uterine Bleeding
3 other identifiers
observational
1,000
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2024
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 30, 2024
CompletedFirst Posted
Study publicly available on registry
February 20, 2024
CompletedStudy Start
First participant enrolled
October 10, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2027
April 16, 2026
April 1, 2026
2.2 years
January 30, 2024
April 13, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Diagnostic Performance of cfDNA Mutation Detection for Endometrial Pathology
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.
Through study completion, anticipated 1-2 years
Association Between Vaginal Microbiome Profile and Endometrial Pathology
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.
Through study completion, anticipated 1-2 years
Study Arms (3)
EIN/EC BIOPSY RESULT
Vaginal samples sequenced. Participation ends here.
EH BIOPSY RESULT
Vaginal samples sequenced. Subset invited to move on to longitudinal monitoring and samples sequenced for 6 additional months.
NEGATIVE BIOPSY RESULT
Control for natural and spontaneous changes in vaginal samples sequenced. Random subset selected to move on to longitudinal monitoring and samples sequenced for 6 additional months.
Eligibility Criteria
The study investigators will have 10-15 study gynecologists across British Columbia, Canada, who will be recruiting study participants from patients who are referred to them for an endometrial biopsy due to abnormal uterine bleeding. The investigators aim to recruit \~1000 participants in Study Part A in order to achieve their target sample size of n=50 EIN/EC and n=150 EH. Sequenced participants will be invited to participate in Study Part B/ Longitudinal monitoring and provide additional samples.
You may qualify if:
- Study Part A:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
VGH Research Pavilion
Vancouver, British Columbia, V5Z 1M9, Canada
Related Publications (1)
Pfeiffer RM, Park Y, Kreimer AR, Lacey JV Jr, Pee D, Greenlee RT, Buys SS, Hollenbeck A, Rosner B, Gail MH, Hartge P. Risk prediction for breast, endometrial, and ovarian cancer in white women aged 50 y or older: derivation and validation from population-based cohort studies. PLoS Med. 2013;10(7):e1001492. doi: 10.1371/journal.pmed.1001492. Epub 2013 Jul 30.
PMID: 23935463BACKGROUND
Biospecimen
Vaginal DNA Vaginal microbiome Vaginal pH
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Aline Talhouk, PhD
University of British Columbia
- PRINCIPAL INVESTIGATOR
Anna Tinker, MD
University of British Columbia
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 30, 2024
First Posted
February 20, 2024
Study Start
October 10, 2024
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
January 1, 2027
Last Updated
April 16, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share