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Risk Evaluation and Screening to Tailor Prevention and Reduce the Incidence of Endometrial Cancer
Sponsor: University of British Columbia
Summary
This study proposes to assess feasibility and acceptability of screening and risk reducing interventions in individuals at increased for endometrial cancer (EC). The investigators will use an epidemiological risk model to participants' absolute risk of developing EC in the next 10 years. Those whose absolute risk is 2% or greater or who have a Body Mass Index (BMI) higher than 34.9 will proceed to a second screening test (the Progesterone Challenge Test or the PCT) used to identify those with endometrial proliferation. The PCT consists of taking a ten-day course of medroxyprogesterone acetate (Provera) 10 mg per os daily. If withdrawal bleeding is experienced during the ten days up to two weeks since the final dose, this is considered a positive test result. PCT positive participants will receive standard of care treatment which may include endometrial biopsy and hormone therapy. As part of this project, the investigators will test the utility of self-collected vaginal sampling to measure DNA mutations and microbiome characteristics to help refine who could forego an endometrial biopsy in the future. Participants identified through the PCT will receive a lifestyle intervention through the Small Steps for Big Changes program.
Official title: Uterine Cancer Risk Reducing Strategies in Postmenopausal Women
Key Details
Gender
FEMALE
Age Range
Any - Any
Study Type
INTERVENTIONAL
Enrollment
250
Start Date
2023-03-15
Completion Date
2025-12
Last Updated
2025-08-29
Healthy Volunteers
Yes
Conditions
Interventions
Provera
Progesterone Challenge Test
Locations (1)
VGH Research Pavilion
Vancouver, British Columbia, Canada