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

NCT02862652 | Completed

• 1 other identifier: PA13047
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (1)

• Presence of microparticules

  Presence of microparticles investigated using flow cytometry

  Day 0

Secondary Outcomes (10)

• Presence of microparticules

  Day 8

• Presence of microparticules

  Day 15

• Presence of microparticules

  Day 25

• Presence of microparticules

  Day 36

• expression of the tissue factor

  Day 0

Study Arms (1)

children with acute lymphoblastic leukemia

EXPERIMENTAL

Other: Blood sample

Interventions

Blood sample OTHER

Blood sample to quantify microparticles and to study expression and activity of the tissue factor on their surface

children with acute lymphoblastic leukemia

Eligibility Criteria

• Age: Up to 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• children with acute lymphoblastic leukemia
• children and their parents consenting to participate to the study
• children enrolled in the national healthcare insurance program

Sponsors & Collaborators

• CHU de Reims: lead

Study Sites (1)

Chu de Reims

Reims, 51092, France

Location

Related Publications (1)

• Pluchart C, Barbe C, Poitevin G, Audonnet S, Nguyen P. A pilot study of procoagulant platelet extracellular vesicles and P-selectin increase during induction treatment in acute lymphoblastic leukaemia paediatric patients: two new biomarkers of thrombogenic risk? J Thromb Thrombolysis. 2021 Apr;51(3):711-719. doi: 10.1007/s11239-020-02346-7. Epub 2020 Nov 28.

  PMID: 33247807 BACKGROUND

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2016
• First Posted: August 11, 2016
• Study Start: May 1, 2014
• Primary Completion: March 21, 2017
• Study Completion: March 21, 2017
• Last Updated: January 21, 2026

Record last verified: 2017-03

Locations

FR (1)