Clinical trial · Interventional
Risk Evaluation and Screening to Tailor Prevention and Reduce the Incidence of Endometrial Cancer
Uterine Cancer Risk Reducing Strategies in Postmenopausal Women
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrium Cancer | Endometrial Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Provera | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Progesterone Challenge Test
- description
- 10-day course of medroxyprogesterone acetate (Provera) 10 mg per os (po) daily.
- interventionNames
- Drug: Provera
Primary outcomes (2)
- measure
- Feasibility of Proposed Screening Method
- timeFrame
- Through study completion, an average of 1 year
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
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)
References
Publications (6)
- BACKGROUNDHarris 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
- BACKGROUNDObeid 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
- BACKGROUNDHarris 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
- BACKGROUNDPfeiffer 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
- BACKGROUNDHart 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
- BACKGROUNDLarsen 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