Clinical trial · Observational
The Clinical Utility of DNA Methylation Testing in Patient-collected Urine and Vaginal Samples to Detect Endometrial Cancer: a Case-control Study
A Case-control Study of the Clinical Utility of DNA Methylation Testing in Patient-collected Vaginal and Urine Samples: A Novel, Patient-friendly and Simple Diagnostic Solution to Detect Endometrial Cancer.
NCT06846775CI-TRIAL-00101616recruitingClinicalTrials.gov clinicaltrialsProvenance
- 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)
The goal of this observational case-control study is to investigate the use of DNA-methylation testing in patient-collected urine and vaginal samples to detect endometrial cancer. The study aims to answer the following questions: * Can DNA methylation testing in vaginal and full-void urine samples distinguish endometrial cancer cases from healthy controls? Researchers will compare patient-collected urine and vaginal samples from patients with diagnosed endometrial cancer (cases) to gynaecologically and oncologically healthy controls (controls). Participants will * take a urine and vaginal sample at the hospital. * answer a questionnaire regarding acceptability and preferences of self-sampling methods. * answer a lifestyle questionnaire.
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 |
|---|---|---|---|
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DNA-methylation testing in patient-collected urine and vaginal samples | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Women with endometrial cancer
- description
- Women with diagnosed endometrial cancer ≥ 60 years, without any other concurrent cancer diagnoses. All participants will be asked to collect a urine and vaginal sample, fill out a life style questionnaire and a questionnaire about user experience and preferences.
- interventionNames
- Diagnostic Test: DNA-methylation testing in patient-collected urine and vaginal samples
- label
- Healthy controls
- description
- Gynaecologically and oncolocigally healthy controls ≥ 60 years. All participants will be asked to collect a urine and vaginal sample, fill out a life style questionnaire and a questionnaire about user experience and preferences.
- interventionNames
- Diagnostic Test: DNA-methylation testing in patient-collected urine and vaginal samples
Primary outcomes (1)
- measure
- Area Under the Curve
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 60 Years
Show eligibility criteria text
Patients with endometrial cancer (cases): Inclusion Criteria: * Women ≥ 60 years * Diagnosed with cancer corpus uteri * Living in Central Denmark Region or Southern Denmark Region, Denmark * Able to provide written consent for participation * Able to read and understand Danish Patients with endometrial cancer (cases): Exclusion Criteria: * Other concurrent cancer diagnosis besides cancer corpus uteri * Withdrawal of consent Healthy controls: Inclusion Criteria: * Postmenopausal women ≥ 60 years * Living in Central Denmark Region, Denmark * Able to provide written consent for participation * Able to read and understand Danish Healthy controls: Exclusion Criteria: * Diagnosed with cancer or undergoing diagnostic assessment herfore without the last 5 years. * Vaginal bleeding within the last 3 months. * Known gynaecological diseases such as cervical dysplasia or atypical endomatrial hyperplasia within the last 5 years. * Previously hysterectomized * Withdrawal of consent.
References
Publications (24)
- BACKGROUNDErichsen R, Lash TL, Hamilton-Dutoit SJ, Bjerregaard B, Vyberg M, Pedersen L. Existing data sources for clinical epidemiology: the Danish National Pathology Registry and Data Bank. Clin Epidemiol. 2010 Aug 9;2:51-6. doi: 10.2147/clep.s9908. PMID 20865103
- BACKGROUNDEvans I, Reisel D, Jones A, Bajrami A, Nijjar S, Solangon SA, Arora R, Redl E, Schreiberhuber L, Ishaq-Parveen I, Rotharmel J, Herzog C, Jurkovic D, Widschwendter M. Performance of the WID-qEC test versus sonography to detect uterine cancers in women with abnormal uterine bleeding (EPI-SURE): a prospective, consecutive observational cohort study in the UK. Lancet Oncol. 2023 Dec;24(12):1375-1386. doi: 10.1016/S1470-2045(23)00466-7. Epub 2023 Nov 6. PMID 37944542
- BACKGROUNDVan Keer S, van Splunter AP, Pattyn J, De Smet A, Herzog SA, Van Ostade X, Tjalma WAA, Ieven M, Van Damme P, Steenbergen RDM, Vorsters A. Triage of human papillomavirus infected women by methylation analysis in first-void urine. Sci Rep. 2021 Apr 12;11(1):7862. doi: 10.1038/s41598-021-87329-1. PMID 33846517
- BACKGROUNDGuerrero-Preston R, Valle BL, Jedlicka A, Turaga N, Folawiyo O, Pirini F, Lawson F, Vergura A, Noordhuis M, Dziedzic A, Perez G, Renehan M, Guerrero-Diaz C, De Jesus Rodriguez E, Diaz-Montes T, Rodriguez Orengo J, Mendez K, Romaguera J, Trock BJ, Florea L, Sidransky D. Molecular Triage of Premalignant Lesions in Liquid-Based Cervical Cytology and Circulating Cell-Free DNA from Urine, Using a Panel of Methylated Human Papilloma Virus and Host Genes. Cancer Prev Res (Phila). 2016 Dec;9(12):915-924. doi: 10.1158/1940-6207.CAPR-16-0138. Epub 2016 Sep 26. PMID 27671338
- BACKGROUNDSnoek BC, Splunter APV, Bleeker MCG, Ruiten MCV, Heideman DAM, Rurup WF, Verlaat W, Schotman H, Gent MV, Trommel NEV, Steenbergen RDM. Cervical cancer detection by DNA methylation analysis in urine. Sci Rep. 2019 Feb 28;9(1):3088. doi: 10.1038/s41598-019-39275-2. PMID 30816167
- BACKGROUNDWever BMM, van den Helder R, van Splunter AP, van Gent MDJM, Kasius JC, Trum JW, Verhoeve HR, van Baal WM, Hulbert A, Verhoef L, Heideman DAM, Lissenberg-Witte BI, van Trommel NE, Steenbergen RDM, Bleeker MCG. DNA methylation testing for endometrial cancer detection in urine, cervicovaginal self-samples and cervical scrapes. Int J Cancer. 2023 Jul 15;153(2):341-351. doi: 10.1002/ijc.34504. Epub 2023 Mar 23.