RecruitingNCT06268626

Detection of Endometrial Cancer Through Risk Modelling

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

Sponsor

University of British Columbia

Enrollment

1,000 participants

Start Date

Oct 10, 2024

Study Type

OBSERVATIONAL

Conditions

Endometrial Cancer

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.

Eligibility

Sex: FEMALEMin Age: 40 Years

Inclusion Criteria7

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.

Exclusion Criteria7

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