Recruiting

Observational StudyDetection of Endometrial Cancer Through Risk Modelling

Sponsor:

University of British Columbia

Code:

NCT06268626

Conditions

Endometrial Cancer

Eligibility Criteria

Sex: Female

Age: 40+

Healthy Volunteers: Accepted

Study Details

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.

Conditions

Endometrial Cancer

Study ID

NCT06268626

Start date

Oct 10, 2024

Status verified date

Apr, 2026

Completion date

Jan, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Sex: Female

Age: 40+

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

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Aline Talhouk, PhD

+1 (604) 875-4111 a.talhouk@ubc.ca

Jennifer Ellis-White

+1 (604) 875-4111 jelliswh@student.ubc.ca

Locations

VGH Research Pavilion

Recruiting

Vancouver, British Columbia, Canada, V5Z 1M9

Contacts

Aline Talhouk, PhD

+1 (604) 875-4111 a.talhouk@ubc.ca

Jennifer Ellis-White, BSc

+1 (604) 875-4111 jelliswh@student.ubc.ca

Principal Investigator:

Aline Talhouk, PhD

More Information

Sponsor

University of British Columbia

Last update posted

Apr 16, 2026

Last verified

Apr, 2026

Keywords

Screening
Prevention
Women's Health
Reproductive health
Abnormal Uterine Bleeding

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2026-04-16.