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- Ensayo clínico NCT00899834
DNA Analysis of Tumor Tissue Samples From Patients With Diffuse Brain Stem Glioma
25 de julio de 2016 actualizado por: St. Jude Children's Research Hospital
Comprehensive Molecular Analysis of Tumor Samples Derived From Patients With Diffuse Brainstem Glioma - A Pilot Study
This multi-institutional study will prospectively collect tumor and constitutional tissue samples from patients with diffuse brainstem glioma and other types of brainstem gliomas either during therapy or at autopsy to perform an extensive analysis of genetic and molecular abnormalities in these tumors.
Descripción general del estudio
Estado
Terminado
Descripción detallada
Since very little is known about the biology of diffuse brainstem glioma, the goal of this protocol is to undertake a systematic analysis of DNA abnormalities, and of RNA and protein expression in prospectively collected fresh-frozen and fixed tumor samples and correspondent normal tissue from patients affected with this tumor.
OBJECTIVES:
- Perform genome-wide analysis of DNA gains and losses and RNA expression in tumor samples and normal tissue from patients with diffuse brain stem glioma.
- Identify regions of genomic gain or loss using either array comparative genomic hybridization or single nucleotide polymorphism arrays.
- Investigate genome-wide expression patterns of RNA derived from tumor samples and normal tissue from these patients via Affymetrix gene expression profiling.
- Validate the results of the genome-wide analysis by conducting further evaluation of candidate genes or by investigating the expression of relevant gene products at the RNA and protein levels.
- Perform analysis of mutations in candidate tumor-suppressor genes and oncogenes (including whole genome sequencing studies) using direct sequence analysis of tumor DNA and confirm the tumor-specific nature of these mutations by analyzing the correspondent constitutional DNA.
- Confirm genomic gains or losses identified by means of fluorescence in situ hybridization (FISH) performed on tissue microarray using non-neoplastic brain tissue from each patient as control when available.
- Explore protein expression patterns identified by immunohistochemistry or western blot and compare them to normal brain stem tissue.
- To obtain a follow-up (questionnaire and/or telephone interview) after autopsy with parent(s), legal guardian(s), or family members of research participants in the United States to assess aspects associated with this procedure, including potential benefits and drawbacks
Tipo de estudio
De observación
Inscripción (Actual)
81
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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California
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Palo Alto, California, Estados Unidos, 94305
- Stanford University Medical Center
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Tennessee
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Memphis, Tennessee, Estados Unidos, 38105
- St. Jude Children's Research Hospital
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Washington
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Seattle, Washington, Estados Unidos, 98105
- Seattle Children's Hospital
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
No mayor que 18 años (Niño, Adulto)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
Fresh-frozen and fixed tumor samples and correspondent normal tissue from patients affected with this tumor (peripheral blood is applicable only to patients with focal brainstem gliomas and patients who undergo biopsy of a diffuse brainstem glioma at diagnosis)
Descripción
Inclusion Criteria
- Patients of any age with clinical and radiologic diagnosis of diffuse brainstem glioma
- Patients with other high-grade gliomas originating in the brainstem
- Patients with focal gliomas (WHO grade I/II) of the brainstem
- Enrollment in the current version of the St. Jude Tissue Bank protocol for patients whose tissue samples were obtained at diagnosis and who received treatment at St. Jude Children's Research Hospital (SJCRH), or correspondent tissue banking consent for patients treated in other institutions if tissue was obtained prior to death (as applicable, depending on the standard of each institution)
Exclusion Criteria
- Patients with any type of infiltrative low-grade (WHO grade II) or high-grade glioma (WHO grade III and IV) originating outside the brainstem
- Patients harboring primary brainstem tumors with other histologic diagnoses (e.g., PNET)
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Tumor Samples
fresh-frozen and fixed tumor samples and correspondent normal tissue from patients affected with this tumor.(peripheral
blood is applicable only to patients with focal brainstem gliomas and patients who undergo biopsy of a diffuse brainstem glioma at diagnosis)
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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DNA gains and losses and RNA expression in tumor samples and normal tissue
Periodo de tiempo: at autopsy
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Tissue samples will be obtained at autopsy.
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at autopsy
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Genome-wide expression patterns of RNA in tumor samples and normal tissue as assessed by Affymetrix gene expression profiling
Periodo de tiempo: at autopsy
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Tissue samples will be obtained at autopsy.
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at autopsy
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Validation of results of the genome-wide analysis
Periodo de tiempo: at autopsy
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Tissue samples will be obtained at autopsy.
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at autopsy
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Mutations in candidate tumor-suppressor genes and oncogenes as assessed by direct sequencing analysis of tumor DNA
Periodo de tiempo: at autopsy
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Tissue samples will be obtained at autopsy.
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at autopsy
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Confirmation of the tumor-specific nature of candidate tumor-suppressor gene and oncogene mutation as assessed by the correspondent constitutional DNA
Periodo de tiempo: at autopsy
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Tissue samples will be obtained at autopsy.
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at autopsy
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Confirmation of genomic gains or losses as assessed by fluorescence in situ hybridization (FISH) performed on tissue microarray (TMA) using non-neoplastic brain tissue
Periodo de tiempo: at autopsy
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Tissue samples will be obtained at autopsy.
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at autopsy
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Protein expression patterns as assessed by immunohistochemistry or western blot compared to normal brain stem tissue
Periodo de tiempo: at autopsy
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Tissue samples will be obtained at autopsy.
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at autopsy
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Assess aspects associated with this procedure, including potential benefits and drawbacks
Periodo de tiempo: at autopsy
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Tissue samples will be obtained at autopsy.
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at autopsy
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Alberto Broniscer, MD, St. Jude Children's Research Hospital
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de junio de 2006
Finalización primaria (Actual)
1 de agosto de 2015
Finalización del estudio (Actual)
1 de agosto de 2015
Fechas de registro del estudio
Enviado por primera vez
9 de mayo de 2009
Primero enviado que cumplió con los criterios de control de calidad
9 de mayo de 2009
Publicado por primera vez (Estimar)
12 de mayo de 2009
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
26 de julio de 2016
Última actualización enviada que cumplió con los criterios de control de calidad
25 de julio de 2016
Última verificación
1 de julio de 2016
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades del Sistema Nervioso
- Neoplasias por tipo histológico
- Neoplasias por sitio
- Neoplasias Glandulares y Epiteliales
- Neoplasias Neuroepiteliales
- Tumores neuroectodérmicos
- Neoplasias De Células Germinales Y Embrionarias
- Neoplasias De Tejido Nervioso
- Neoplasias
- Glioma
- Neoplasias del Sistema Nervioso
- Neoplasias del Sistema Nervioso Central
Otros números de identificación del estudio
- NBTP02-SJ
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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