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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. (THROMBLEUKEMIA)

Primary Purpose

Acute Lymphoblastic Leukemia

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood sample
Sponsored by
CHU de Reims
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Acute Lymphoblastic Leukemia

Eligibility Criteria

undefined - 16 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chu de Reims

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

children with acute lymphoblastic leukemia

Arm Description

Outcomes

Primary Outcome Measures

Presence of microparticules
Presence of microparticles investigated using flow cytometry

Secondary Outcome Measures

Presence of microparticules
Presence of microparticles investigated using flow cytometry
Presence of microparticules
Presence of microparticles investigated using flow cytometry
Presence of microparticules
Presence of microparticles investigated using flow cytometry
Presence of microparticules
Presence of microparticles investigated using flow cytometry
expression of the tissue factor
expression of the tissue factor investigated using flow cytometry
expression of the tissue factor
expression of the tissue factor investigated using flow cytometry
expression of the tissue factor
expression of the tissue factor investigated using flow cytometry
expression of the tissue factor
expression of the tissue factor investigated using flow cytometry
expression of the tissue factor
expression of the tissue factor investigated using flow cytometry
Thromboembolic complication
complication thromboembolic diagnosed by the clinical examination and by the imaging

Full Information

First Posted
August 8, 2016
Last Updated
March 31, 2017
Sponsor
CHU de Reims
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1. Study Identification

Unique Protocol Identification Number
NCT02862652
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.
Acronym
THROMBLEUKEMIA
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
May 2014 (Actual)
Primary Completion Date
March 21, 2017 (Actual)
Study Completion Date
March 21, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CHU de Reims

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lymphoblastic Leukemia

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
children with acute lymphoblastic leukemia
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Blood sample
Intervention Description
Blood sample to quantify microparticles and to study expression and activity of the tissue factor on their surface
Primary Outcome Measure Information:
Title
Presence of microparticules
Description
Presence of microparticles investigated using flow cytometry
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
Presence of microparticules
Description
Presence of microparticles investigated using flow cytometry
Time Frame
Day 8
Title
Presence of microparticules
Description
Presence of microparticles investigated using flow cytometry
Time Frame
Day 15
Title
Presence of microparticules
Description
Presence of microparticles investigated using flow cytometry
Time Frame
Day 25
Title
Presence of microparticules
Description
Presence of microparticles investigated using flow cytometry
Time Frame
Day 36
Title
expression of the tissue factor
Description
expression of the tissue factor investigated using flow cytometry
Time Frame
Day 0
Title
expression of the tissue factor
Description
expression of the tissue factor investigated using flow cytometry
Time Frame
Day 3
Title
expression of the tissue factor
Description
expression of the tissue factor investigated using flow cytometry
Time Frame
Day 15
Title
expression of the tissue factor
Description
expression of the tissue factor investigated using flow cytometry
Time Frame
Day 25
Title
expression of the tissue factor
Description
expression of the tissue factor investigated using flow cytometry
Time Frame
Day 36
Title
Thromboembolic complication
Description
complication thromboembolic diagnosed by the clinical examination and by the imaging
Time Frame
Day 36

10. Eligibility

Sex
All
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Chu de Reims
City
Reims
ZIP/Postal Code
51092
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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