Methylation analyses using home-based self-sampling in women with and without gynecological disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The MARGOT study collects self-sampled first-void urine and vaginal material from adults to compare biomarker patterns with samples from individuals diagnosed with gynecological (pre-)cancers. Cancer-free controls are recruited through social media, volunteer databases, and healthcare posters, and may collect samples at home or at the study center. A questionnaire gathers information on risk factors and experiences with self-sampling while samples are analyzed using the Colli-Pee device with UCM and Evalyn Brush. The study aims to better understand differences in biological markers between these groups and to validate reference populations for future biomarker research. This is an interventional study with self-sampling as the core procedure, conducted at the University of Antwerp and affiliated centers.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Individuals having female genital organs, regardless of their gender identity.
* Participant is 18 years or older at the time of signing the informed consent form.
* Participant must be able to understand the (Dutch) information consent form and what the study is about.
* Participant must be able to provide written informed consent and take urine- and vaginal self-samples.
* Individual has a Belgian nationality.

Exclusion Criteria:

* Individuals that underwent hysterectomy or ovariectomy.
* Pregnant individuals or 6 months post-partum.
* (History of) (pre)cancer, or an ongoing diagnostic work-up or treatment for oncological concerns.
* Unable to give informed consent or to take urine- or vaginal self-samples.
* Participation in another interventional study. However, participation in another low-interventional or observational study is allowed.
* Individuals who have (a history) of postmenopausal bleeding.

Where it's running

• University of Antwerp, Center for the Evaluation of Vaccination, Vaccinopolis
  Edegem, Antwerp, Belgium Recruiting

Study contacts

• Principal investigator: Wiebren A.A. Tjalma, MD, PhD — Universiteit Antwerpen
• Study coordinator: Tine Pinxteren, MSc
• Email: tine.pinxteren@uantwerpen.be
• Phone: 476014843

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.