Risk Evaluation and Screening to Tailor Prevention and Reduce the Incidence of Endometrial Cancer
Status:
Not yet recruiting
Trial end date:
2023-10-01
Target enrollment:
Participant gender:
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 3% or greater 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.
Phase:
Phase 4
Details
Lead Sponsor:
University of British Columbia
Collaborators:
Canadian Cancer Society (CCS) Canadian Institutes of Health Research (CIHR)