An interventional study of Colli-Pee 20 mL device with UCM and Evalyn Brush in Gynaecological Cancers, Ovarian Cancer and Endometrial Cancer, sponsored by Universiteit Antwerpen. Recruiting at 1 site in Belgium. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by Universiteit Antwerpen · Not applicable, Interventional, and Diagnostic
The goal of the MYSSELF study is to investigate which biological markers (i.e., (epi)genetic biomarkers) found in self-collected samples, such as first-void urine and vaginal samples, are linked to the presence of endometrial, ovarian, vulvar, or vaginal (pre-)cancer or to postmenopausal bleeding. Samples collected by clinicians from the cervix or vulva, as well as blood and tissue samples, will be used for comparison. The study will explore whether these markers could help improve earlier and less invasive detection of gynecological cancers in the future.
Gynecological cancers include cancers of the cervix, endometrium, ovaries, vulva, and vagina. Early detection of these cancers is important, because treatment is more effective before the disease has advanced. At the moment, cervical cancer is the only gynecological cancer with a population-based screening program. For the other types (endometrial, ovarian, vulvar, and vaginal cancer), only diagnostic methods are available, but these are often uncomfortable for patients or not sufficiently specific. Hence, this study aims to improve early detection by looking for new biological markers (i.e., (epi)genetic biomarkers) in less-invasive samples that are associated with the presence of gynecological cancers. For this, different sample types are collected from patients with endometrial, ovarian, vulvar, or vaginal (pre-)cancer (n=100/(pre-)cancer) or from individuals with postmenopausal bleeding (n=330). These samples include self-samples collected at home (first-void urine (Colli-Pee 20 mL prefilled with urine conservation medium (UCM)) and vaginal self-sample (Evalyn brush)), clinician-collected cervical/vulvar samples, and blood samples. Only when a tissue sample is already being taken as part of the participant's standard treatment or diagnostic follow-up, it will be used for this study as well. As such, participants do not undergo additional invasive procedures as part of the study. All these samples are collected before any treatment begins (e.g., surgery, chemotherapy, radiotherapy…). For all analyses, 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. A questionnaire will provide more information about the presence of risk factors and participants' experiences with the self-sampling methods.
2,763 studies on the registry are indexed under Ovarian Neoplasms; 735 are open to participants now.
This study's planned enrollment of 730 is above the median of 59 across 2,079 interventional studies indexed under Ovarian Neoplasms.
Browse Ovarian Neoplasms studies →Universiteit Antwerpen is the lead sponsor of 135 studies on the registry; 32 are open to participants now.
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Inclusion Criteria:
Exclusion Criteria:
Exclusion criteria related to blood withdrawal
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.
Device: Colli-Pee 20 mL device with UCM · Device: Evalyn Brush
Participants will collect a first-void urine (the initial part of the urine stream) sample with the 20 mL Colli-Pee device prefilled with urine conservation medium (UCM, DNA Genotek, Canada). This sample can be taken at home the day before or the day of the planned consultation at the hospital or at the hospital itself.
Participants will collect a vaginal self-sample with the Evalyn Brush (Rovers Medical Devices, The Netherlands) at home the day before or the day of the planned consultation at the hospital or at the hospital itself.
Number and overview of biomarkers associated with the presence of gynecological (pre-)cancers
The primary objective of this study is to determine the feasibility of detecting (epi)genetic biomarkers in participants with (pre-)cancer (endometrial, ovarian, vulvar, or vaginal cancer). This evaluation will be conducted using multiple sample types: self-samples (first-void urine and vaginal samples), clinician-collected cervical/vulvar samples, blood samples, and tissue samples.
Time frame: 48 months
Comparison of the biomarkers in different sample types
The secondary objective is to compare the presence of biomarkers across different sample types (self-samples (first-void urine and vaginal samples), clinician-collected cervical/vulvar samples, blood samples, and tissue samples).
Time frame: 48 months
Association of biomarkers and presence of postmenopausal bleeding
The third objective is to explore the association of the identified biomarkers with clinical characteristics in individuals with postmenopausal bleeding, a symptom that can arise from a variety of conditions, including but not limited to endometrial cancer.
Time frame: 72 months
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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