Activación de eosinófilos en trastornos eosinofílicos
Colección de datos
Recopilados desde hoy en adelante - ProspectivoEnfermedades bronquiales+13
+ Enfermedades Hematológicas
+ Enfermedades hemáticas y linfáticas
Cohorte
Seguimiento de la incidencia de una enfermedad para identificar factores de riesgo y comprender su progresión a lo largo del tiempo.Resumen
Fecha de inicio: 21 de abril de 1997
Fecha en la que se inscribió al primer participante.Study Description: This study is designed to collect data and clinical samples from participants with elevated eosinophil counts in the peripheral blood or tissues or their relatives to enhance our understanding of the mechanisms driving eosinophilia and eosinophil activation in patients with a wide range of eosinophilic disorders with the ultimate goal of improving diagnostics and identifying novel treatment modalities for these patients. Eosinophilic participants will undergo an extensive clinical evaluation at baseline and at least yearly thereafter focused on the identification of the cause of eosinophilia and the presence of end organ manifestations. Blood, bone marrow, tissue, and/or body fluids will be collected for research purposes at initial and follow-up visits to address broader questions relating to the varied etiologies of eosinophilia, biomarkers of disease activity and eosinophil activation, and the functional role of eosinophils in homeostasis and disease pathogenesis. While this protocol is not primarily designed to study treatment of eosinophilic patients, the clinical and immunological responses to therapy will be monitored. This protocol will also allow clinical and laboratory evaluation of family members of subjects with eosinophilia to help identify genetic causes of eosinophilia and to provide controls for immunologic studies. Objectives: Primary Objective: to understand the mechanisms driving eosinophilia and eosinophil activation in patients with a wide range of eosinophilic disorders Secondary Objectives: 1. To develop a diagnostic algorithm that accurately classifies eosinophilic patients by underlying etiology 2. To determine the mechanisms underlying eosinophil activation and recruitment to the blood and tissues 3. To understand the mechanisms of action of therapeutic agents used or in development for the treatment of HES 4. To assess the signs and symptoms experienced by patients with HES Exploratory Objectives: 1. To investigate the multifunctional role of eosinophils in settings other than HES 2. To understand the long-term effects of eosinophilia in patients with HES 3. To assess the effects of race, sex, ethnicity, and environmental factors on the prevalence and clinical manifestations of eosinophilic disorders Endpoints: Primary Endpoint: Identification and characterization of clinical and genetic variants of hypereosinophilic syndromes (HES) Secondary Endpoints: 1\. Identification of laboratory and clinical tests that distinguish between clinical and genetic variants of HES 2a. Identification of biomarkers of disease activity and specific organ involvement in eosinophilic disorders 2b. Identification of new therapeutic targets for the treatment of HES 3\. Delineation of the effects of therapeutic agents on eosinophil development, activation, recruitment to tissues and/or apoptosis 4\. Creation of a patient-related outcomes questionnaire for use in future treatment studies of HES Exploratory Endpoints: 1. Description of the consequences of eosinophilia and/or eosinophil depletion in the context of varied immunologic and inflammatory settings 2. Collection of standardized longitudinal data on disease activity and outcome in patients with hypereosinophilia. 3. Comparison of prevalence and clinical manifestations of eosinophilic disorders among varied subpopulations of patients
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 800 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Cohorte
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.De 1 a 100 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.Un solo grupo de intervención está designado en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Objetivos del Estudio
Objetivos Primarios
Objetivos Secundarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene una ubicación
National Institutes of Health Clinical Center
Bethesda, United StatesAbrir National Institutes of Health Clinical Center en Google Maps