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.
Studienübersicht
Status
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Tine Pinxteren, MSc
- Telefonnummer: 32 476014843
- E-Mail: tine.pinxteren@uantwerpen.be
Studienorte
-
-
Antwerp
-
Edegem, Antwerp, Belgien, 2650
- Rekrutierung
- University of Antwerp, Center for the Evaluation of Vaccination, Vaccinopolis
-
Kontakt:
- Tine Pinxteren, MSc
- Telefonnummer: 32 04 76 01 48 43
- E-Mail: CEV-HPVstudies@uantwerpen.be
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Diagnose
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Comparison of (epi)genetic biomarkers between controls and cases
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Wiebren A.A. Tjalma, MD, PhD, Universiteit Antwerpen
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- B3002026000034
Plan für individuelle Teilnehmerdaten (IPD)
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Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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