Methylation Analyses for Gynaecological Research Through Home-based Self-sampling (MARGOT)
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Tine Pinxteren, MSc
- Telefonnummer: 32 476014843
- E-mail: tine.pinxteren@uantwerpen.be
Studiesteder
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-
Antwerp
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Edegem, Antwerp, Belgien, 2650
- Rekruttering
- University of Antwerp, Center for the Evaluation of Vaccination, Vaccinopolis
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Kontakt:
- Tine Pinxteren, MSc
- Telefonnummer: 32 04 76 01 48 43
- E-mail: CEV-HPVstudies@uantwerpen.be
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Participants Providing Self-Samples for Biomarker Analysis
Participants will collect one first-void urine sample and one vaginal self-sample at home or at the study center. |
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. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Comparison of (epi)genetic biomarkers between controls and cases
Tidsramme: 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. |
48 months
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Wiebren A.A. Tjalma, MD, PhD, Universiteit Antwerpen
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- B3002026000034
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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