Neurobehavioral Outcomes in Childhood Acute Lymphoblastic Leukemia. A Limited Non-Therapeutic Study
Colección de datos
Recopilados desde hoy en adelante - ProspectivoEnfermedades Hematológicas+8
+ Enfermedades del sistema inmunitario
+ Trastornos Inmunoproliferativos
Resumen
Fecha de inicio: 1 de mayo de 2004
Fecha en la que se inscribió al primer participante.OBJECTIVES: * Compare neurobehavioral functioning, specifically memory, attention, executive function, visual-motor integration, and processing speed, in children previously treated with steroids (prednisone vs dexamethasone) and intrathecal therapy (methotrexate alone vs methotrexate, cytarabine, and hydrocortisone) for childhood acute lymphoblastic leukemia. * Correlate non-treatment risk factors, such as gender, age at diagnosis, and time since termination of prior therapy, with impaired neurobehavioral function in these patients. * Correlate neurobehavioral complications with quality-of-life of these patients. OUTLINE: This is a multicenter, cohort study. Patients are assigned to 1 of 2 cohorts (prior treatment per CCG-1922 \[prednisone vs dexamethasone\] vs prior treatment per CCG-1952 \[intrathecal (IT) methotrexate vs IT methotrexate, cytarabine, and hydrocortisone\]). Patients in each cohort are stratified according to age at diagnosis, gender, and time since prior treatment termination. * Cohort A (CCG-1922): Patients undergo physical and neurological examination, neurobehavioral evaluation, and quality of life assessment. Neurobehavioral evaluations assess memory, attention, and executive function. * Cohort B (CCG-1952): Patients undergo evaluation as above. Neurobehavioral evaluations assess visual-motor integration and processing speed. PROJECTED ACCRUAL: A total of 448 patients (224 per cohort) will be accrued for this study within 4 years.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 286 pacientes
Número total de participantes que el ensayo clínico espera reclutar.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 6 a 16 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
DISEASE CHARACTERISTICS: * Diagnosis of standard-risk childhood acute lymphoblastic leukemia (ALL) * In continuous first remission * No history of CNS pathology requiring radiotherapy or surgery * Prior enrollment on one of the following Children's Cancer Group (CCG) protocols AND terminated therapy at least 1 year ago: * CCG-1922 (prednisone vs dexamethasone) * CCG-1952 (intrathecal methotrexate vs triple intrathecal therapy) * No prior enrollment on CCG-1952 arm III * No history of pre-existing neurodevelopmental disorder before diagnosis of ALL (e.g., mental retardation, Down syndrome, seizure disorder, or traumatic brain injury) * No neuropsychological assessment within the past 6 months PATIENT CHARACTERISTICS: Age * 6.5 to 16 years Performance status * Not specified Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Not specified Renal * Not specified Other * Reading, speaking, and listening comprehension of English by patient required (English and/or Spanish by parent) * No history of very low birth weight (\< 1,500 grams) PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * See Disease Characteristics Endocrine therapy * See Disease Characteristics Radiotherapy * See Disease Characteristics Surgery * See Disease Characteristics Other * Concurrent stimulants allowed
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.Objetivos del Estudio
Objetivos Primarios
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 31 ubicaciones
Loma Linda University Cancer Institute at Loma Linda University Medical Center
Loma Linda, United StatesJonathan Jaques Children's Cancer Center at Miller Children's Hospital
Long Beach, United StatesChildrens Hospital Los Angeles
Los Angeles, United States