Brain Integrity in Survivors of Hodgkin Lymphoma (HL) Treated With Thoracic Radiation
Colección de datos
+ other Data
+ other Data
Enfermedades hemáticas y linfáticas+6
+ Enfermedades del sistema inmunitario
+ Trastornos Inmunoproliferativos
Casos y Controles
Examen de las características de personas con una enfermedad para identificar factores genéticos o ambientales que contribuyen a la condición.Resumen
Fecha de inicio: 26 de abril de 2013
Fecha en la que se inscribió al primer participante.This is an observational study to collect health data from long-term survivors of Hodgkin lymphoma (HL). Data will be collected once at participant enrollment. The long-term effects of thoracic radiation therapy (TRT) given earlier as part of the treatment for HL will be examined in long-term survivors and compared to health data collected from normal volunteers. HL survivors who were treated at St. Jude Children's Research Hospital (SJCRH) with TRT will be recruited to complete a comprehensive neurocognitive evaluation, brain MRI/MRA, a clinical neurological exam, peripheral pulse contour analysis, non-invasive central blood pressure monitoring, cardiopulmonary exercise testing, and serum biomarkers related to cardiac disease. As part of their standard St. Jude LIFE protocol evaluation, they also complete an echocardiogram, pulmonary function tests and questionnaires designed to evaluate broad health, psychological, socioeconomic and environmental factors that impact everyday life. A comparison sample of healthy individuals, frequency-matched on age, sex and race will also be recruited. The comparison group will complete the comprehensive neurocognitive evaluation, brain MRI/MRA, clinical neurological exam, pulse contour analysis, non-invasive central blood pressure monitoring, and cardiopulmonary exercise testing. Through the St. Jude LIFE protocol, the comparison sample will also complete an echocardiogram, pulmonary function tests and questionnaires designed to evaluate broad health, psychological, socioeconomic and environmental factors that impact everyday life.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 416 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Casos y Controles
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.A partir de 18 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
Inclusion Criteria - HL participant: Current St. Jude LIFE protocol Participant, treated with thoracic radiation Currently ≥ 18 years of age ≥ 10 years from original diagnosis Exclusion Criteria - HL participant: Has participated in the previous pilot study at St. Jude (HPP16) History of cranial or total-body radiation therapy History of intrathecal Methotrexate, high-dose Methotrexate or high-dose Cytarabine. History of head injury or diagnosis of a genetic disorder associated with neurocognitive impairment Pre-existing known neurocognitive impairment prior to diagnosis of Hodgkin lymphoma History of congenital heart disease reported in the literature to be associated with neurocognitive status as determined by the principal investigators Currently pregnant Secondary central nervous system neoplasm Inclusion Criteria - Normal Control: Research participant is a sibling, parent, relative or friend of a current or former St. Jude patient Research participant must be at least 18 years of age at the time of the scheduled evaluation Exclusion Criteria - Normal Control: History of cranial, total-body or thoracic radiation therapy History of intrathecal Methotrexate, high-dose Methotrexate, or high-dose Cytarabine. History of head injury or diagnosis of a genetic disorder associated with neurocognitive impairment Known neurocognitive impairment History of congenital heart disease reported in the literature to be associated with neurocognitive status as determined by the principal investigators Currently pregnant Central nervous system neoplasm
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.2 grupos de intervención están designados 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
St. Jude Children's Research Hospital
Memphis, United StatesAbrir St. Jude Children's Research Hospital en Google Maps