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.
研究概览
详细说明
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
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
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Reims、法国、51092
- CHU de Reims
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的?
设计细节
- 主要用途:基础科学
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:children with acute lymphoblastic leukemia
|
Blood sample to quantify microparticles and to study expression and activity of the tissue factor on their surface
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Presence of microparticules
大体时间:Day 0
|
Presence of microparticles investigated using flow cytometry
|
Day 0
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Presence of microparticules
大体时间:Day 8
|
Presence of microparticles investigated using flow cytometry
|
Day 8
|
Presence of microparticules
大体时间:Day 15
|
Presence of microparticles investigated using flow cytometry
|
Day 15
|
Presence of microparticules
大体时间:Day 25
|
Presence of microparticles investigated using flow cytometry
|
Day 25
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Presence of microparticules
大体时间:Day 36
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Presence of microparticles investigated using flow cytometry
|
Day 36
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expression of the tissue factor
大体时间:Day 0
|
expression of the tissue factor investigated using flow cytometry
|
Day 0
|
expression of the tissue factor
大体时间:Day 3
|
expression of the tissue factor investigated using flow cytometry
|
Day 3
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expression of the tissue factor
大体时间:Day 15
|
expression of the tissue factor investigated using flow cytometry
|
Day 15
|
expression of the tissue factor
大体时间:Day 25
|
expression of the tissue factor investigated using flow cytometry
|
Day 25
|
expression of the tissue factor
大体时间:Day 36
|
expression of the tissue factor investigated using flow cytometry
|
Day 36
|
Thromboembolic complication
大体时间:Day 36
|
complication thromboembolic diagnosed by the clinical examination and by the imaging
|
Day 36
|
合作者和调查者
赞助
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
急性淋巴细胞白血病的临床试验
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Shenzhen Second People's Hospital招聘中白血病 | 骨髓的 | 慢性的 | BCR-ABL (Breakpoint Cluster Region-abelson Murine Leukemia) | 积极的中国