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.

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Diagnostic test
Study Type: Observational
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
Participation Requirements
Sex: Female
Minimum Age: 60
Healthy Volunteers: t
View:

• 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

• Postmenopausal women ≥ 60 years

• Living in Central Denmark Region, Denmark

• Able to provide written consent for participation

• Able to read and understand Danish

Locations
Other Locations
Denmark
Department of Obstetrics and Gynaecology, Aarhus University Hospital
RECRUITING
Aarhus N
Department of Obstetrics and Gynaecology, Odense University Hospital
RECRUITING
Odense
Department of Orthopaedics, Randers Regional Hospital
NOT_YET_RECRUITING
Randers
Contact Information
Primary
Karen O. Binderup
kabind@rm.dk
+4578420187
Backup
Mette Tranberg, PhD
mettrani@rm.dk
+4578420264
Time Frame
Start Date: 2025-04-15
Estimated Completion Date: 2027-11-30
Participants
Target number of participants: 120
Treatments
Women with endometrial cancer
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.
Healthy controls
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.
Related Therapeutic Areas
Sponsors
Collaborators: University of Southern Denmark, Region of Southern Denmark, Central Denmark Region, Amsterdam UMC
Leads: University of Aarhus

This content was sourced from clinicaltrials.gov