Detection of Endometrial Cancer Through Risk Modelling (DETECTR)

April 13, 2026 updated by: Aline Talhouk, University of British Columbia

Non-Invasive Strategies for Early Detection of Uterine Cancer in Patients With Abnormal Uterine Bleeding

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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Purpose:

To improve the prediction of EC and its precursors by integrating data from questionnaires and biological biomarkers obtained from non-invasive tests (vaginal DNA and microbiome swabs, vaginal pH). We also want to better understand pre-malignant disease progression and identify opportunities for earlier intervention.

Hypotheses:

  1. Risk factors in combination with ultrasound data, and patterns of abnormal bleeding are associated with endometrial cancer and its precursors.
  2. Prediction of pathology is improved by including mutation and microbiome data from noninvasive tests combined with traditional risk factors.
  3. Persistence of mutations and microbiome alterations is more common in patients with endometrial hyperplasia than other benign diagnoses and is associated with lifestyle factors.

Justification:

Non-invasive tests and questionnaires may be used to predict onset of endometrial carcinoma or its precursors and can be used to triage those participants with abnormal bleeding who require an endometrial biopsy.

Objectives:

To enhance understanding of the progression of EC and propose non-invasive methods for detection in patients who are experiencing abnormal uterine bleeding and have already been referred to a gynecologist for an endometrial biopsy.

Research Design:

This is a prospective case-cohort study that will recruit n=1000+ participants over the age of 35 years whose abnormal uterine bleeding is being evaluated via endometrial biopsy. Prospective participants will consent to access the information in their medical records, including access to their pathology report. A subset of participants (n=450) will be invited to self-collect vaginal DNA and microbiome samples using swabs and vaginal pH using a litmus kit for sequencing and analysis. A subset of those who retain their uterus (i.e. are not directed to a hysterectomy per standard clinical management) (n=200+), will be invited to take part in longitudinal monitoring using a wearable fitness tracker (Fitbit) and questionnaires, and an additional vaginal self-collection.

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Aline Talhouk, PhD
  • Phone Number: 21365 +1 (604) 875-4111
  • Email: a.talhouk@ubc.ca

Study Contact Backup

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Recruiting
        • VGH Research Pavilion
        • Contact:
          • Aline Talhouk, PhD
          • Phone Number: 21365 +1 (604) 875-4111
          • Email: a.talhouk@ubc.ca
        • Principal Investigator:
          • Aline Talhouk, PhD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic Performance of cfDNA Mutation Detection for Endometrial Pathology
Time Frame: 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.
Through study completion, anticipated 1-2 years
Association Between Vaginal Microbiome Profile and Endometrial Pathology
Time Frame: 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.
Through study completion, anticipated 1-2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Collaborators

Canadian Institutes of Health Research (CIHR)

Investigators

  • Principal Investigator: Aline Talhouk, PhD, University of British Columbia
  • Principal Investigator: Anna Tinker, MD, University of British Columbia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2024

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

January 30, 2024

First Submitted That Met QC Criteria

February 12, 2024

First Posted (Actual)

February 20, 2024

Study Record Updates

Last Update Posted (Actual)

April 16, 2026

Last Update Submitted That Met QC Criteria

April 13, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H22-02426
  • F22-01302 (Other Grant/Funding Number: Canadian Institutes of Health Research (CIHR))
  • F21-03695 (Other Grant/Funding Number: Canadian Institutes of Health Research (CIHR))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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