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Role of the Microparticles and of Tissue Factor in the Pro-thrombotic Phenotype and the Thromboembolic Complications During the Acute Lymphoblastic Leukemia in Children.

Disease Information

Descriptive Information
Brief Title † Role of the Microparticles and of Tissue Factor in the Pro-thrombotic Phenotype and the Thromboembolic Complications During the Acute Lymphoblastic Leukemia in Children.
Official Title † Role of the Microparticles and of Tissue Factor in the Pro-thrombotic Phenotype and the Thromboembolic Complications During the Acute Lymphoblastic Leukemia in Children
Brief Summary 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.
Detailed Description 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
Study Phase N/A
Study Type † Interventional
Study Design †
Primary Outcome Measure † Presence of microparticules
Secondary Outcome Measure † Presence of microparticules
Condition † Acute Lymphoblastic Leukemia
Intervention † OtherBlood sample
Study Arms / Comparison Groups children with acute lymphoblastic leukemia
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Other
Estimated Enrollment † 24
Start Date † May 2014
Completion Date March 21, 2017
Primary Completion Date March 21, 2017
Eligibility Criteria † 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
Gender All
Ages N/A - 16 Years
Accepts Healthy Volunteers No
Contacts ††
Location Countries † France
Administrative Information
NCT ID † NCT02862652
Organization ID PA13047
Secondary IDs ††
Responsible Party Sponsor
Study Sponsor † CHU de Reims
Collaborators ††
Investigators † : ,
Information Provided By
Verification Date March 2017
First Received Date † August 8, 2016
Last Updated Date March 31, 2017
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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