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ACTIVE NOT RECRUITING
NCT05651282
PHASE4

Risk Evaluation and Screening to Tailor Prevention and Reduce the Incidence of Endometrial Cancer

Sponsor: University of British Columbia

View on ClinicalTrials.gov

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

Interventions

DRUG

Provera

Progesterone Challenge Test

Locations (1)

VGH Research Pavilion

Vancouver, British Columbia, Canada