Detection of Endometrial Cancer Through Risk Modelling

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

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

Conditions2

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