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MYSSELFNCT07902375

Methylation Profiling in Self-samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers

StatusRecruiting
PhaseNot applicable
Primary completion (estimated)
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Record History

All 1 version: 1 with changes below.

  1. Study First Submitted

Endpoints

Primary

Number and overview of biomarkers associated with the presence of gynecological (pre-)cancers
Timeframe: 48 months

Secondary (2)

Comparison of the biomarkers in different sample types
Association of biomarkers and presence of postmenopausal bleeding

Arms and interventions

Sample collectionExperimental

Participants will collect one first-void urine sample and one vaginal self-sample at home, the day before or the day of their planned consultation at the hospital or at the hospital itself. During the hospital visit, an additional clinician-collected cervical and/or vulvar sample and a blood sample will be collected for the study. If a tissue sample is already being taken as part of the participant's standard treatment or diagnostic follow-up, it will also be used for this study. Current diagnostic results (e.g., dilation \& curettage, transvaginal ultrasonography, blood biomarker CA-125, vulvoscopy, echography, imaging (CT, PET, MRI)) and cancer (histology) diagnoses will be used as the final diagnosis.

Devices: Colli-Pee 20 mL device with UCM, Evalyn Brush

Sites

1 site in 1 country

  • University Hospital of Antwerp (UZA)Edegem, Antwerp, Belgium