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NOT YET RECRUITING
NCT06268626

Detection of Endometrial Cancer Through Risk Modelling

Sponsor: University of British Columbia

View on ClinicalTrials.gov

Summary

The goal of this study is to combine information on risk factors from health questionnaires with minimally invasive biological tests (vaginal DNA and microbiome swabs, pH, hormones) to predict the risk of endometrial cancer (EC), better understand progression of the disease, and identify opportunities for intervention. This study will recruit patients who are already scheduled to undergo diagnostic evaluation for abnormal uterine bleeding via endometrial biopsy. In Part A, consented participants will be asked to fill out an online risk factor questionnaire. Samples will be collected by the gynecologist at the biopsy appointment. After biopsy results are obtained, all samples from participants diagnosed with EC or precursors, plus a random subset with benign results, will be selected to be sequenced and analyzed. In Part B, that subset of selected non-malignant participants, based on biopsy, will be invited to take part in lifestyle tracking using a Fitbit, questionnaires, and to provide another round of at-home vaginal samples to identify any persistent genetic mutations or microbiome alterations 6-8 months later.

Official title: Minimally Invasive Strategies for Early Detection of Uterine Cancer in Patients With Abnormal Uterine Bleeding

Key Details

Gender

FEMALE

Age Range

40 Years - Any

Study Type

OBSERVATIONAL

Enrollment

1000

Start Date

2024-04

Completion Date

2027-01

Last Updated

2024-02-20

Healthy Volunteers

Yes

Locations (1)

VGH Research Pavilion

Vancouver, British Columbia, Canada