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Taking people in DenmarkNo phase

Tests a urine and vaginal sample method for detecting endometrial cancer

Compares self-collected urine and vaginal samples from women with endometrial cancer and healthy women.

Plain-language title generated from the registry record
Registry title: The Clinical Utility of DNA Methylation Testing in Patient-collected Urine and Vaginal Samples to Detect Endometrial Cancer: a Case-control Study

Key facts

Where
Aarhus N, Odense, and Randers, DenmarkSee the 3 sites

Where in Denmark

  • Department of Obstetrics and Gynaecology, Aarhus University HospitalAarhus N, DenmarkTaking people
  • Department of Obstetrics and Gynaecology, Odense University HospitalOdense, DenmarkTaking people
  • Department of Orthopaedics, Randers Regional HospitalRanders, DenmarkTaking people

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Trial details

Who runs it
University of Aarhus
Trial code
NCT06846775
Record updated
26 January 2026
Original description
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:Read full original descriptionShow less

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.

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.

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.

ClinicalTrials.gov NCT06846775