Brain Tumors Clinical Trial
Official title:
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.
Status | Completed |
Enrollment | 81 |
Est. completion date | August 2015 |
Est. primary completion date | August 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 18 Years |
Eligibility |
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) |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | St. Jude Children's Research Hospital | Memphis | Tennessee |
United States | Stanford University Medical Center | Palo Alto | California |
United States | Seattle Children's Hospital | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
St. Jude Children's Research Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | DNA gains and losses and RNA expression in tumor samples and normal tissue | Tissue samples will be obtained at autopsy. | at autopsy | No |
Primary | Genome-wide expression patterns of RNA in tumor samples and normal tissue as assessed by Affymetrix gene expression profiling | Tissue samples will be obtained at autopsy. | at autopsy | No |
Primary | Validation of results of the genome-wide analysis | Tissue samples will be obtained at autopsy. | at autopsy | No |
Primary | Mutations in candidate tumor-suppressor genes and oncogenes as assessed by direct sequencing analysis of tumor DNA | Tissue samples will be obtained at autopsy. | at autopsy | No |
Primary | Confirmation of the tumor-specific nature of candidate tumor-suppressor gene and oncogene mutation as assessed by the correspondent constitutional DNA | Tissue samples will be obtained at autopsy. | at autopsy | No |
Primary | Confirmation of genomic gains or losses as assessed by fluorescence in situ hybridization (FISH) performed on tissue microarray (TMA) using non-neoplastic brain tissue | Tissue samples will be obtained at autopsy. | at autopsy | No |
Primary | Protein expression patterns as assessed by immunohistochemistry or western blot compared to normal brain stem tissue | Tissue samples will be obtained at autopsy. | at autopsy | No |
Secondary | Assess aspects associated with this procedure, including potential benefits and drawbacks | Tissue samples will be obtained at autopsy. | at autopsy | No |
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