NCT06268626

Detection of Endometrial Cancer Through Risk Modelling

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: University of British Columbia · Academic / Other
• Sex: Female
• Age: 40 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Endometrial Cancer

Timeline

• Start date: 2024-10-10
• Primary completion: 2027-01-01
• Completion: 2027-01-01
• First posted: 2024-02-20
• Last updated: 2026-04-16

Locations

1 site across 1 country: Canada