81 DNA methylation testing for endometrial cancer detection in patient-friendly sample types methylation analysis of these markers in paired urine, cervicovaginal self-samples and clinician-taken cervical scrapes. METHODS Study population Paired minimally- and non-invasive samples from endometrial cancer patients Paired samples from endometrial cancer patients were collected within the SOLUTION1 study, between October 2016 and August 2020. Our study included patients diagnosed with endometrial cancer irrespective of FIGO (2009) stage and histological subtype. From each patient, a urine sample, a cervicovaginal self-sample, and a cliniciantaken cervical scrape were collected before primary treatment. A complete urine void was collected at home, irrespective of time of collection and personal hygiene. The cervicovaginal self-sample was also collected at home after urine collection. The clinician-taken cervical scrape was collected in the operating room, prior to surgery. In case the clinician-taken cervical scrape was not collected, the residual cytology sample of the cervical scrape that was taken for clinical diagnostics was used. Unpaired minimally- and non-invasive samples from healthy women For comparison, unpaired urine samples, cervicovaginal self-samples, and cliniciantaken cervical scrapes from healthy female controls were included. Urine controls were obtained through the Urine Controls (URIC) biobank. Controls were selected for eligibility based on a questionnaire in which age, sex, and cancer history was documented. Only controls without any cancer history in the past 5 years were included. A subset of urine samples was previously used and published (25). Cervicovaginal self-samples and clinician-taken cervical scrapes were derived from leftover material of the Dutch national cervical cancer screening program coordinated by the Dutch National Institute for Public Health and the Environment (RIVM). Selection was based on age and a negative high-risk HPV test. Selected controls were similar to cases with respect to age. Tissue samples Methylation markers GHSR, SST, and ZIC1 were previously discovered for cervical cancer detection (26), but also appeared diagnostically relevant for endometrial cancer detection in urine (25). To verify that increased methylation levels originate from the endometrial tumor, formalin-fixed paraffin-embedded (FFPE) tissue specimens of a subset of endometrial cancer patients from the SOLUTION1 study were also tested. FFPE tissues of normal endometrium were collected from patients with early-stage ovarian cancer without metastases to the endometrium who underwent a surgical 4
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