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The Clinical Utility of DNA Methylation Testing in Patient-collected Urine and Vaginal Samples to Detect Endometrial Cancer: a Case-control Study

NCT06846775 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2026-01-26

No results posted yet for this study

Summary

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

Interventions

DIAGNOSTIC_TEST

DNA-methylation testing in patient-collected urine and vaginal samples

DNA-methylation testing of methylation markers CDO1, GHSR and ZIC1 for patient-collected vaginal samples and GHSR, CDH13 and SST for patient-collected urine samples.

Sponsors & Collaborators

  • Central Denmark Region

    collaborator OTHER

  • University of Southern Denmark

    collaborator OTHER

  • Region of Southern Denmark

    collaborator OTHER

  • Amsterdam UMC

    collaborator OTHER

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Mette Tranberg · University Research Clinic for Cancer Screening, Department of Public Health Programmes, Randers Regional Hospital

Eligibility

Min Age
60 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-04-15
Primary Completion
2026-02-28
Completion
2028-01-30

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06846775 on ClinicalTrials.gov