Role of the Microparticles and of Tissue Factor in the Pro-thrombotic Phenotype and the Thromboembolic Complications During the Acute Lymphoblastic Leukemia in Children. (THROMBLEUKEMIA)
Role of the Microparticles and of Tissue Factor in the Pro-thrombotic Phenotype and the Thromboembolic Complications During the Acute Lymphoblastic Leukemia in Children
Acute lymphoblastic leukemia is the most common malignancy of the child. Current therapeutic strategies allow healing of over 80% of children. However these treatments are associated with toxicity, with a mortality of 1-2%. The most frequent complications, occuring during treatment initiation, are the thromboembolic complications.
The most commonly accepted explanation is that of an anti-thrombin depletion by chemotherapy used in the treatment, L-asparaginase. But the anti-thrombin supplementation showed no efficacy in the prevention of these thromboembolic complications. Therefore most authors consider that a multifactorial mechanism is behind these events, involving both treatment and malignant cells. The interaction of these two factors participate in the damage of the vascular endothelium.
The microparticles are membrane fragments derived from budding from the membrane of activated cells or apoptosis. Their thrombogenic role is linked to the expression of coagulation activators such as tissue factor. It is also associated with their role in the modulation of signaling pathways involved in the invasiveness and angiogenesis in endothelial cells.
In acute lymphoblastic leukemia, the presence and role of microparticles have not been studied. Our hypothesis is that of production of microparticles upon lysis of blasts then upon activation of endothelial cells induced by the induction therapy, participating in a procoagulant phenotype.
調査の概要
詳細な説明
The aims of this study are
- quantify the microparticles in children receiving induction therapy for Acute lymphoblastic leukemia at diagnosis and during treatment
- study the origin of these particles and the expression and activity of the tissue factor on their surface, at diagnosis and during treatment
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Reims、フランス、51092
- CHU de Reims
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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
受講資格のある性別
説明
Inclusion Criteria:
- children with acute lymphoblastic leukemia
- children and their parents consenting to participate to the study
- children enrolled in the national healthcare insurance program
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:基礎科学
- 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 |
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実験的:children with acute lymphoblastic leukemia
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Blood sample to quantify microparticles and to study expression and activity of the tissue factor on their surface
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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 |
---|---|---|
Presence of microparticules
時間枠:Day 0
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Presence of microparticles investigated using flow cytometry
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Day 0
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Presence of microparticules
時間枠:Day 8
|
Presence of microparticles investigated using flow cytometry
|
Day 8
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Presence of microparticules
時間枠:Day 15
|
Presence of microparticles investigated using flow cytometry
|
Day 15
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Presence of microparticules
時間枠:Day 25
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Presence of microparticles investigated using flow cytometry
|
Day 25
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Presence of microparticules
時間枠:Day 36
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Presence of microparticles investigated using flow cytometry
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Day 36
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expression of the tissue factor
時間枠:Day 0
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expression of the tissue factor investigated using flow cytometry
|
Day 0
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expression of the tissue factor
時間枠:Day 3
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expression of the tissue factor investigated using flow cytometry
|
Day 3
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expression of the tissue factor
時間枠:Day 15
|
expression of the tissue factor investigated using flow cytometry
|
Day 15
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expression of the tissue factor
時間枠:Day 25
|
expression of the tissue factor investigated using flow cytometry
|
Day 25
|
expression of the tissue factor
時間枠:Day 36
|
expression of the tissue factor investigated using flow cytometry
|
Day 36
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Thromboembolic complication
時間枠:Day 36
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complication thromboembolic diagnosed by the clinical examination and by the imaging
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Day 36
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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 (見積もり)
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
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。
Blood sampleの臨床試験
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University of UtahAlbert Einstein College of Medicine; University of California, San Francisco; National Human Genome... と他の協力者完了新生児スクリーニング
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Ischemia Care LLC完了虚血性脳卒中 | 心房細動 | 血栓性脳卒中 | 一過性脳虚血発作 | 心塞栓性脳卒中 | 脳底動脈の脳卒中 | 一過性脳血管イベントアメリカ
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Applied Science & Performance Institute完了
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Bedford Hospital NHS TrustAnglia Ruskin Universityわからない