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DNA Analysis of Tumor Tissue Samples From Patients With Diffuse Brain Stem Glioma

25 de julho de 2016 atualizado 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.

Visão geral do estudo

Status

Concluído

Condições

Descrição detalhada

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 estudo

Observacional

Inscrição (Real)

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

Estados Unidos
- California
  - Palo Alto, California, Estados Unidos, 94305
    - Stanford University Medical Center
- Tennessee
  - Memphis, Tennessee, Estados Unidos, 38105
    - St. Jude Children's Research Hospital
- Washington
  - Seattle, Washington, Estados Unidos, 98105
    - Seattle Children's Hospital

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

Não mais velho que 18 anos (Filho, Adulto)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra Não Probabilística

População do estudo

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)

Descrição

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)

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Número de grupos/coortes

Coortes e Intervenções

Grupo / Coorte
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)

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado	Descrição da medida	Prazo
DNA gains and losses and RNA expression in tumor samples and normal tissue Prazo: at autopsy	Tissue samples will be obtained at autopsy.	at autopsy
Genome-wide expression patterns of RNA in tumor samples and normal tissue as assessed by Affymetrix gene expression profiling Prazo: at autopsy	Tissue samples will be obtained at autopsy.	at autopsy
Validation of results of the genome-wide analysis Prazo: at autopsy	Tissue samples will be obtained at autopsy.	at autopsy
Mutations in candidate tumor-suppressor genes and oncogenes as assessed by direct sequencing analysis of tumor DNA Prazo: at autopsy	Tissue samples will be obtained at autopsy.	at autopsy
Confirmation of the tumor-specific nature of candidate tumor-suppressor gene and oncogene mutation as assessed by the correspondent constitutional DNA Prazo: at autopsy	Tissue samples will be obtained at autopsy.	at autopsy
Confirmation of genomic gains or losses as assessed by fluorescence in situ hybridization (FISH) performed on tissue microarray (TMA) using non-neoplastic brain tissue Prazo: at autopsy	Tissue samples will be obtained at autopsy.	at autopsy
Protein expression patterns as assessed by immunohistochemistry or western blot compared to normal brain stem tissue Prazo: at autopsy	Tissue samples will be obtained at autopsy.	at autopsy

Medidas de resultados secundários

Medida de resultado	Descrição da medida	Prazo
Assess aspects associated with this procedure, including potential benefits and drawbacks Prazo: at autopsy	Tissue samples will be obtained at autopsy.	at autopsy

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

St. Jude Children's Research Hospital

Investigadores

Investigador principal: Alberto Broniscer, MD, St. Jude Children's Research Hospital

Publicações e links úteis

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Links úteis

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de junho de 2006

Conclusão Primária (Real)

1 de agosto de 2015

Conclusão do estudo (Real)