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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Tine Pinxteren, MSc
- 電話番号：32 476014843
- メール：tine.pinxteren@uantwerpen.be
研究場所
-
-
Antwerp
-
Edegem、Antwerp、ベルギー、2650
- 募集
- University of Antwerp, Center for the Evaluation of Vaccination, Vaccinopolis
-
コンタクト：
- Tine Pinxteren, MSc
- 電話番号：32 04 76 01 48 43
- メール：CEV-HPVstudies@uantwerpen.be
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：診断
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Comparison of (epi)genetic biomarkers between controls and cases
時間枠：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
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Wiebren A.A. Tjalma, MD, PhD、Universiteit Antwerpen
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- B3002026000034
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。