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: 0
• Participant gender: Female

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
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of British Columbia
• Collaborators: Canadian Cancer Society (CCS); Canadian Institutes of Health Research (CIHR)
• Treatments: Medroxyprogesterone Acetate

Criteria

Inclusion Criteria:

• Individuals are postmenopausal (must be three (3) years past last menstrual period)

• Individuals have an intact uterus (have not had a hysterectomy)

Exclusion Criteria:

• Individuals taking hormone therapy for menopause (including vaginal estrogen)

• Individuals taking male hormones,

• Individuals on anti-endocrine therapy (such as tamoxifen)

• Individuals on aromatase inhibitor therapy

• Individuals who have experienced abnormal uterine bleeding

• Individuals who have an Intrauterine Device (IUD)