- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Reims, Francia, 51092
- CHU de Reims
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: children with acute lymphoblastic leukemia
|
Blood sample to quantify microparticles and to study expression and activity of the tissue factor on their surface
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Presence of microparticules
Periodo de tiempo: Day 0
|
Presence of microparticles investigated using flow cytometry
|
Day 0
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Presence of microparticules
Periodo de tiempo: Day 8
|
Presence of microparticles investigated using flow cytometry
|
Day 8
|
Presence of microparticules
Periodo de tiempo: Day 15
|
Presence of microparticles investigated using flow cytometry
|
Day 15
|
Presence of microparticules
Periodo de tiempo: Day 25
|
Presence of microparticles investigated using flow cytometry
|
Day 25
|
Presence of microparticules
Periodo de tiempo: Day 36
|
Presence of microparticles investigated using flow cytometry
|
Day 36
|
expression of the tissue factor
Periodo de tiempo: Day 0
|
expression of the tissue factor investigated using flow cytometry
|
Day 0
|
expression of the tissue factor
Periodo de tiempo: Day 3
|
expression of the tissue factor investigated using flow cytometry
|
Day 3
|
expression of the tissue factor
Periodo de tiempo: Day 15
|
expression of the tissue factor investigated using flow cytometry
|
Day 15
|
expression of the tissue factor
Periodo de tiempo: Day 25
|
expression of the tissue factor investigated using flow cytometry
|
Day 25
|
expression of the tissue factor
Periodo de tiempo: Day 36
|
expression of the tissue factor investigated using flow cytometry
|
Day 36
|
Thromboembolic complication
Periodo de tiempo: Day 36
|
complication thromboembolic diagnosed by the clinical examination and by the imaging
|
Day 36
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- PA13047
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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