- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00693914
Working Memory Performance Among Childhood Brain Tumor Survivors
Working Memory Performance Among Childhood Brain Tumor Survivors Treated With Conformal Radiation Therapy: A Pilot Study
Children treated with radiation therapy for brain tumors are at risk for cognitive problems. These problems have typically been demonstrated on global cognitive measures including measures of intellectual functioning (IQ). Identification of specific areas of impairment can assist in isolating vulnerable brain areas and developing targeted interventions.
In this study, we assess brain tumor survivors, solid tumor controls and healthy sibling controls using measures of working memory (online maintenance and manipulation of information) in order to identify a specific cognitive process that may underlie the observed decline in IQ. We are also exploring relationships among working memory performance with IQ, clinical characteristics and a specific genetic factor of interest.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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Tennessee
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Memphis, Tennessee, Estados Unidos, 38105
- St. Jude Children's Research Hospital
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
Brain Tumor Patients
- Treated for a primary central nervous system (CNS) tumor with conformal radiation therapy and enrolled on the institutional protocol RT-1
- Initiated radiation therapy at least 2 years prior to enrollment with no evidence of recurrent disease
- Age 8-18 years inclusive at the time of enrollment, with sampling to obtain a broad cross-section of participants in terms of age, tumor location and time since RT initiation
- English as the primary language
- Research participant and one parent willing to participate and provide consent/assent according to institutional guidelines
Solid Tumor Patient Controls
- Treated for a solid tumor (i.e., Ewing's sarcoma, osteosarcoma, soft tissue/rhabdomyosarcoma, neuroblastoma or Wilms tumor) at St. Jude without CNS directed therapy - Diagnosed at least 2 years prior to enrollment
- Age 8-18 inclusive at the time of enrollment, with age, gender and race sampling to broadly match the brain tumor group
- English as the primary language
- Research participant and one parent willing to participate and provide consent/assent according to institutional guidelines
Sibling Controls
- Healthy sibling controls- siblings of St. Jude patients treated for a brain tumor (not necessarily on RT-1)
- Age 8-18 inclusive, with age and gender sampling to broadly match the patient group
- English as a primary language
- Research participant and one parent willing to participate and provide consent/assent according to institutional guidelines
Exclusion Criteria:
Brain Tumor Patients
- Significant impairment in global intellectual functioning (operationalized as an estimated IQ less than 70 as indicated by most recent RT-1 testing)
- History of documented CNS injury or disease predating cancer diagnosis
- History of documented Attention Deficit Hyperactivity Disorder (ADHD) predating cancer diagnosis by at least one year (must have been diagnosed by a physician with medication prescribed)
- Treatment with psychostimulant or psychotropic medication within two weeks of study enrollment
- Sensory or motor impairment that would preclude valid cognitive testing
Solid Tumor and Sibling Controls
- Significant impairment in global intellectual functioning (operationalized as a history of special education in a self-contained classroom)
- History of documented CNS injury or disease
- History of documented Attention Deficit Hyperactivity Disorder (ADHD) (must have been diagnosed by a physician with medication prescribed)
- Treatment with psychostimulant or psychotropic medication within two weeks of study enrollment
- Sensory or motor impairment that would preclude valid cognitive testing
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
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1: Brain Tumor Survivors (n=50)
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Developmental and Demographic, KINDL Health-Related Quality of Life, Adaptive Behavior Assessment System (ABAS-II),Behavior Rating Inventory of Executive Function (BRIEF), Wechsler Digit Span Task, Wide Range Achievement Test 3rd Edition (WRAT3),Wechsler Abbreviated Scale of Intelligence (WASI), Pediatric Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT), Recognition Memory Task: Face Stimuli, Recognition Memory Task: Verbal Stimuli, Self Ordered Search: Object, Self Order Search: Verbal
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2: Healthy Sibling Controls (n=40)
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Developmental and Demographic, KINDL Health-Related Quality of Life, Adaptive Behavior Assessment System (ABAS-II),Behavior Rating Inventory of Executive Function (BRIEF), Wechsler Digit Span Task, Wide Range Achievement Test 3rd Edition (WRAT3),Wechsler Abbreviated Scale of Intelligence (WASI), Pediatric Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT), Recognition Memory Task: Face Stimuli, Recognition Memory Task: Verbal Stimuli, Self Ordered Search: Object, Self Order Search: Verbal
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Solid Tumor Survivors (n=40)
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Developmental and Demographic, KINDL Health-Related Quality of Life, Adaptive Behavior Assessment System (ABAS-II),Behavior Rating Inventory of Executive Function (BRIEF), Wechsler Digit Span Task, Wide Range Achievement Test 3rd Edition (WRAT3),Wechsler Abbreviated Scale of Intelligence (WASI), Pediatric Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT), Recognition Memory Task: Face Stimuli, Recognition Memory Task: Verbal Stimuli, Self Ordered Search: Object, Self Order Search: Verbal
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
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Performance on experimental working memory measures (computerized self-ordered pointing tasks)
Prazo: Collected during one time cross-sectional assessment.
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Collected during one time cross-sectional assessment.
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Medidas de resultados secundários
Medida de resultado |
Prazo |
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Abbreviated IQ (WASI), episodic memory measures (computerized word and face recognition tasks) and parent questionnaires of executive (BRIEF) and adaptive (ABAS-II) functioning.
Prazo: Collected during one time cross-sectional assessment.
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Collected during one time cross-sectional assessment.
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Heather M Conklin, Ph.D., St. Jude Children's Research Hospital
Publicações e links úteis
Links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- EXFXN1
- R21CA131616 (Concessão/Contrato do NIH dos EUA)
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