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

Eligibility

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.

Conditions2

Browse More Trials