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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Tine Pinxteren, MSc
- Numéro de téléphone: 32 476014843
- E-mail: tine.pinxteren@uantwerpen.be
Lieux d'étude
-
-
Antwerp
-
Edegem, Antwerp, Belgique, 2650
- Recrutement
- University of Antwerp, Center for the Evaluation of Vaccination, Vaccinopolis
-
Contact:
- Tine Pinxteren, MSc
- Numéro de téléphone: 32 04 76 01 48 43
- E-mail: CEV-HPVstudies@uantwerpen.be
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Diagnostique
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Comparison of (epi)genetic biomarkers between controls and cases
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Wiebren A.A. Tjalma, MD, PhD, Universiteit Antwerpen
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- B3002026000034
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .