CtDNA 分析検査を使用した 5 つの一般的ながんの早期検出 (K-DETEK)
循環腫瘍 DNA の調査に基づく 5 つの一般的ながんの早期検出における新しい血液検査の評価
これは多施設共同の前向きコホート研究であり、循環腫瘍 DNA (ctDNA) の調査に基づいて、4 つの一般的ながんの早期発見における血液検査を評価することを目的としています。
主な目的: がんの早期発見における血液 ctDNA 検査のパフォーマンス特性を評価すること。
二次的な目的:
- 画像診断検査の結果と比較して、腫瘍の起源を特定する際の検査のパフォーマンス特性を評価します。
- 中リスク群と比較して、高リスク群におけるがん発症のリスクを判定する。
調査の概要
詳細な説明
これは多施設共同の前向きコホート研究で、40歳以上の参加者を募集しており、参加者は慢性疾患の定期的なフォローアップ訪問または年1回の健康診断のために研究病院の外来診療所を受診する。 この研究は、ベトナムのホーチミン市の医科薬科大学および他の協力病院と協力して、医学遺伝研究所で実施されます。
すべての包含/除外基準を満たす潜在的な参加者がこの研究に募集されます。 これらの潜在的な参加者は、研究に登録する前にがんの既往歴があってはなりません。
登録時に、各参加者は、人口統計情報、過去の主な病歴、癌の臨床的警告兆候を提供するための事前に設計されたアンケートに回答し、循環腫瘍 DNA (ctDNA) を分析するために 10 mL の血液を提供します。
各参加者は、ctDNA が検出されるか、ctDNA が検出されないかのいずれかを取得します。
血液中にctDNAが検出された人は、検査結果報告書に記載された腫瘍起源の予測に基づいて、がんのスクリーニング検査と診断検査を受けます。 がんが検査室で確認された場合、患者はベトナム保健省のガイドラインおよび/またはがんに関する国際ガイドラインに従って経過観察および疾患の管理が行われます。 登録後 12 か月 (+/- 1 週間) 後に、これらの患者に連絡して、健康全般、特にがんの状態に関する情報を収集します。
血液中にctDNAが検出されたが、参加者の体内の塊の存在が画像診断検査を使用して検出できなかった人の場合。血液中に ctDNA が存在しない人の場合は、登録後 6 か月 (+/- 1 週間) と 12 か月 (+/- 1 週間) 後に電話で参加者の健康に関する情報を収集します。がんの状態と進行状況(可能であれば)。
登録期間は約6か月程度を予定しております。
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Hanoi、ベトナム
- Hanoi Medical University
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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
サンプリング方法
調査対象母集団
説明
包含基準:
- 入学時の年齢が40歳以上であること
- 臨床的な癌の疑いも、癌と確定した病歴も報告されていない
- 一般的な健康状態とがんの進行に関する情報を収集するために、登録後 6 か月後と 12 か月後に連絡を受けることに同意します(可能な場合)。
- 書面によるインフォームドコンセントの提供
除外基準: 潜在的な参加者が以下の基準のいずれかに該当する場合、その人は研究に登録できません。
- がんの病歴(過去3年以内にがんが確認された、または治療を受けたことがある)
- 過去3年以内の輸血歴または骨髄移植歴
- 研究への参加に同意しない
- 対象者には認知症の臨床症状がある。
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
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 |
時間枠 |
|---|---|
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がんの早期発見における血液ctDNA検査の陽性的中率、陰性的中率
時間枠:登録後12ヶ月
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登録後12ヶ月
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がんの早期発見における検査の感度と特異度
時間枠:登録後12ヶ月
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登録後12ヶ月
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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画像診断検査の結果と比較した、腫瘍の起源を決定するための検査の陽性的中率
時間枠:登録後12ヶ月
|
登録後12ヶ月
|
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中リスク集団と比較した高リスク集団のがん発症率
時間枠:登録後12ヶ月
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登録後12ヶ月
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協力者と研究者
スポンサー
協力者
出版物と役立つリンク
一般刊行物
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研究記録日
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研究の完了 (実際)
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本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- 02GS
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?
IPD プランの説明
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- ICF
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
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