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

NCT05651282 | Completed Phase 4

• 1 other identifier: H22-02290
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Endometrium Cancer

Keywords

Screening; Prevention; Progesterone Challenge Test; Women's Health; Reproductive health; Menopause

Outcome Measures

Primary Outcomes (2)

• Feasibility of Proposed Screening Method

  Feasibility will be measured through rates of study enrollment, drop out, and adherence to intervention protocol. To be considered feasible, the study must meet all three of the following criteria: (1) enrollment and accruals: at least 80% of individuals in the top 30 percentile for risk will agree to and complete the PCT; (2) retention: at least a 50% overall retention rate after eligibility from first screen to 3 months post intervention; (3) adherence: at least 75% of participants compliant with interventions as directed (i.e. participating in at least five of the six SSBC sessions). If either accrual, retention, or adherence criteria is violated, the study will be deemed not feasible.

  Through study completion, an average of 1 year

• Acceptability of Proposed Screening Method

  Acceptability will be measured through a standardized and validated survey of satisfaction with therapeutic services, the Client Satisfaction Questionnaire-8 (CSQ-8). Acceptability will be defined as a group median score ≥28 (scores range from 8 to 32) on the CSQ-8. Program evaluation items will be analyzed descriptively. The investigators will use analysis of variance to determine whether the feasibility or acceptability varied by social gender, socio demographic, ethnic, age, body size, or geographic location.

  Through study completion, an average of 1 year

Secondary Outcomes (1)

• Proposed Screening Method Program Evaluation

  Through study completion, an average of 1 year

Study Arms (1)

Progesterone Challenge Test

EXPERIMENTAL

10-day course of medroxyprogesterone acetate (Provera) 10 mg per os (po) daily.

Drug: Provera

Interventions

Provera DRUG

Progesterone Challenge Test

Progesterone Challenge Test

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals are postmenopausal (must be three (3) years past last menstrual period)
• Individuals have an intact uterus (have not had a hysterectomy)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Canadian Cancer Society (CCS): collaborator
• University of British Columbia: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

VGH Research Pavilion

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Related Publications (6)

• Harris PA, Taylor R, Minor BL, Elliott V, Fernandez M, O'Neal L, McLeod L, Delacqua G, Delacqua F, Kirby J, Duda SN; REDCap Consortium. The REDCap consortium: Building an international community of software platform partners. J Biomed Inform. 2019 Jul;95:103208. doi: 10.1016/j.jbi.2019.103208. Epub 2019 May 9.

  PMID: 31078660 BACKGROUND

• Obeid JS, McGraw CA, Minor BL, Conde JG, Pawluk R, Lin M, Wang J, Banks SR, Hemphill SA, Taylor R, Harris PA. Procurement of shared data instruments for Research Electronic Data Capture (REDCap). J Biomed Inform. 2013 Apr;46(2):259-65. doi: 10.1016/j.jbi.2012.10.006. Epub 2012 Nov 10.

  PMID: 23149159 BACKGROUND

• Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30.

  PMID: 18929686 BACKGROUND

• Pfeiffer RM, Park Y, Kreimer AR, Lacey JV Jr, Pee D, Greenlee RT, Buys SS, Hollenbeck A, Rosner B, Gail MH, Hartge P. Risk prediction for breast, endometrial, and ovarian cancer in white women aged 50 y or older: derivation and validation from population-based cohort studies. PLoS Med. 2013;10(7):e1001492. doi: 10.1371/journal.pmed.1001492. Epub 2013 Jul 30.

  PMID: 23935463 BACKGROUND

• Hart GR, Yan V, Huang GS, Liang Y, Nartowt BJ, Muhammad W, Deng J. Population-Based Screening for Endometrial Cancer: Human vs. Machine Intelligence. Front Artif Intell. 2020 Nov 24;3:539879. doi: 10.3389/frai.2020.539879. eCollection 2020.

  PMID: 33733200 BACKGROUND

• Larsen DL, Attkisson CC, Hargreaves WA, Nguyen TD. Assessment of client/patient satisfaction: development of a general scale. Eval Program Plann. 1979;2(3):197-207. doi: 10.1016/0149-7189(79)90094-6. No abstract available.

  PMID: 10245370 BACKGROUND

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Medroxyprogesterone Acetate

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Medroxyprogesterone; Hydroxyprogesterones; Progesterone; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Aline Talhouk, PhD

  University of British Columbia, Department of Obstetrics and Gynecology

  PRINCIPAL INVESTIGATOR

• Jessica McAlpine, MD

  University of British Columbia, Department of Obstetrics and Gynecology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: All eligible participants will move into the various steps of the trial.

Study Record Dates

• First Submitted: October 11, 2022
• First Posted: December 15, 2022
• Study Start: March 15, 2023
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)