An interventional study of Colli-Pee 20 mL device with UCM and Evalyn Brush in Healthy Adult Participants and Gynecological Disease, sponsored by Universiteit Antwerpen. Recruiting at 1 site in Belgium. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by Universiteit Antwerpen · Not applicable, Interventional, and Diagnostic
The goal of the MARGOT study is to collect self-samples, such as first-void urine and vaginal samples, from people without cancer and compare them with samples from people with gynecological (pre-)cancers collected in other studies, to better understand the differences in biological markers present in these samples between these two groups.
To ensure the validity and interpretability of research findings, it is essential to compare study outcomes against an appropriate reference population. This study will collect first-void urine and vaginal self-samples from people without cancer (cancer-free controls), which will serve as a comparator for individuals diagnosed with a gynecological (pre-)cancer. These cancer-free controls are recruited via different ways (e.g., social media, volunteer databases, posters/flyers in healthcare institutions). Participants have the option to collect their samples at home or on site at the study center. A questionnaire will provide more information about the presence of risk factors and participants' experiences with the self-sampling methods.
158 studies on the registry are indexed under Genital Diseases, Female; 33 are open to participants now.
This study's planned enrollment of 512 is above the median of 80 across 114 interventional studies indexed under Genital Diseases, Female.
Browse Genital Diseases, Female studies →Universiteit Antwerpen is the lead sponsor of 135 studies on the registry; 32 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants will collect one first-void urine sample and one vaginal self-sample at home or at the study center.
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 or on site.
Participants will collect a vaginal self-sample with the Evalyn Brush (Rovers Medical Devices, The Netherlands) at home or on site.
Comparison of (epi)genetic biomarkers between controls and cases
The data collected within this study (controls) will be compared to the data from the gynecological (pre-)cancer patients (cases) that are collected during a concurrent study: COMBISCREEN (B3002023000030) and MYSSELF study (B3002025000175). The primary objective of the presented MARGOT study is to facilitate the identification of (epi)genetic biomarkers for the detection of gynecological (pre-)cancers. This will be achieved through the recruitment of sufficient healthy volunteers for a robust comparison of control and (pre-)cancer samples. This evaluation will be conducted using first-void urine and vaginal self-samples that are analysed with (methylation-) detection techniques.
Time frame: 48 months
Other open studies at University of Antwerp, Center for the Evaluation of Vaccination, Vaccinopolis, Edegem
Open a list, then choose Watch this search to get new studies there in a weekly email.
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 ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.