Healthy Adult Participants, Gynecological Disease
Conditions
Keywords
Biomarkers, Self-sampling, First-void urine, Vaginal self-sample, Screening
Brief summary
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.
Detailed description
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.
Interventions
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.
DEVICEEvalyn Brush
Participants will collect a vaginal self-sample with the Evalyn Brush (Rovers Medical Devices, The Netherlands) at home or on site.
Sponsors
Universiteit Antwerpen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of (epi)genetic biomarkers between controls and cases | 48 months | 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. |
Countries
Belgium
Contacts
CONTACTTine Pinxteren, MSc
PRINCIPAL_INVESTIGATORWiebren A.A. Tjalma, MD, PhD
Universiteit Antwerpen
Outcome results
None listed