尿路上皮癌患者の予後バイオマーカー
2021年4月29日 更新者:Hellenic Cooperative Oncology Group
プラチナ処方で治療された尿路上皮癌患者における予後バイオマーカーの研究
膀胱がん(BC)は、悲惨な転帰を伴う不均一な悪性腫瘍です。治療にもかかわらず、MIBC の 5 年全生存率は 50% 未満であり、多くの患者は無反応または無力であり、最も反応する可能性が高い、または治療に適している患者を選択するためのバイオマーカーが必要です。
調査の概要
状態
完了
条件
詳細な説明
この研究では、最も頻繁に変異する遺伝子間の関連性および臨床病理学的特徴との関連性、ならびに全生存期間 (OS) の観点から、上位の変異遺伝子および DNA 損傷応答 (DDR) 変異遺伝子における変異の存在の予後的重要性が評価されました。
さらに、全体的な腫瘍浸潤リンパ球(TIL)密度が測定され、PD-L1、4 つの MMR タンパク質(MLH1、MSH2、MSH6、および PMS2)および腫瘍または間質 CD8+ 細胞傷害性 T リンパ球浸潤の発現が免疫組織化学的に分析され、それらの関連性が評価されました。相互、上位の変異遺伝子、および利用可能な臨床病理学的パラメーターとそれらの予後における役割。
研究の種類
観察的
入学 (実際)
66
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
サンプリング方法
非確率サンプル
調査対象母集団
これは、プラチナ療法で治療された尿路上皮癌患者からの生体サンプルを用いた国境を越えた分析です。
患者は、Hellenic Cooperative Oncology Group (HeCOG) 関連の腫瘍科で治療を受けています。
説明
包含基準:
- 膀胱に位置する尿路上皮癌
- 患者はネオアジュバント時にプラチナレジメンで治療された。 アジュバント設定
- 生物学的材料の使用に関する書面によるインフォームドコンセント
除外基準:
-
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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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尿路上皮癌患者における変異プロファイルの評価
時間枠:最長5年
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最長5年
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二次結果の測定
結果測定 |
時間枠 |
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変異プロファイルとPD-L1発現の関連
時間枠:最長5年
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最長5年
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全生存期間に関する突然変異の予後的重要性の関連
時間枠:最長5年
|
最長5年
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
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研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2000年5月1日
一次修了 (実際)
2017年3月1日
研究の完了 (実際)
2017年6月1日
試験登録日
最初に提出
2021年4月29日
QC基準を満たした最初の提出物
2021年4月29日
最初の投稿 (実際)
2021年5月4日
学習記録の更新
投稿された最後の更新 (実際)
2021年5月4日
QC基準を満たした最後の更新が送信されました
2021年4月29日
最終確認日
2021年4月1日
詳しくは
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。
膀胱がんの臨床試験
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