- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02862652
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
-
Reims, Frankrike, 51092
- CHU de Reims
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Grundläggande vetenskap
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: children with acute lymphoblastic leukemia
|
Blood sample to quantify microparticles and to study expression and activity of the tissue factor on their surface
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Presence of microparticules
Tidsram: Day 0
|
Presence of microparticles investigated using flow cytometry
|
Day 0
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Presence of microparticules
Tidsram: Day 8
|
Presence of microparticles investigated using flow cytometry
|
Day 8
|
Presence of microparticules
Tidsram: Day 15
|
Presence of microparticles investigated using flow cytometry
|
Day 15
|
Presence of microparticules
Tidsram: Day 25
|
Presence of microparticles investigated using flow cytometry
|
Day 25
|
Presence of microparticules
Tidsram: Day 36
|
Presence of microparticles investigated using flow cytometry
|
Day 36
|
expression of the tissue factor
Tidsram: Day 0
|
expression of the tissue factor investigated using flow cytometry
|
Day 0
|
expression of the tissue factor
Tidsram: Day 3
|
expression of the tissue factor investigated using flow cytometry
|
Day 3
|
expression of the tissue factor
Tidsram: Day 15
|
expression of the tissue factor investigated using flow cytometry
|
Day 15
|
expression of the tissue factor
Tidsram: Day 25
|
expression of the tissue factor investigated using flow cytometry
|
Day 25
|
expression of the tissue factor
Tidsram: Day 36
|
expression of the tissue factor investigated using flow cytometry
|
Day 36
|
Thromboembolic complication
Tidsram: Day 36
|
complication thromboembolic diagnosed by the clinical examination and by the imaging
|
Day 36
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- PA13047
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