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Clinical Trials/NCT00899834
NCT00899834
Completed
N/A

Comprehensive Molecular Analysis of Tumor Samples Derived From Patients With Diffuse Brainstem Glioma - A Pilot Study

St. Jude Children's Research Hospital3 sites in 1 country81 target enrollmentJune 2006

Overview

Phase
N/A
Intervention
Not specified
Conditions
Brain Tumors
Sponsor
St. Jude Children's Research Hospital
Enrollment
81
Locations
3
Primary Endpoint
DNA gains and losses and RNA expression in tumor samples and normal tissue
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

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.

Detailed Description

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

Registry
clinicaltrials.gov
Start Date
June 2006
End Date
August 2015
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

DNA gains and losses and RNA expression in tumor samples and normal tissue

Time Frame: at autopsy

Tissue samples will be obtained at autopsy.

Genome-wide expression patterns of RNA in tumor samples and normal tissue as assessed by Affymetrix gene expression profiling

Time Frame: at autopsy

Tissue samples will be obtained at autopsy.

Validation of results of the genome-wide analysis

Time Frame: at autopsy

Tissue samples will be obtained at autopsy.

Mutations in candidate tumor-suppressor genes and oncogenes as assessed by direct sequencing analysis of tumor DNA

Time Frame: at autopsy

Tissue samples will be obtained at autopsy.

Confirmation of the tumor-specific nature of candidate tumor-suppressor gene and oncogene mutation as assessed by the correspondent constitutional DNA

Time Frame: at autopsy

Tissue samples will be obtained at autopsy.

Protein expression patterns as assessed by immunohistochemistry or western blot compared to normal brain stem tissue

Time Frame: at autopsy

Tissue samples will be obtained 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

Time Frame: at autopsy

Tissue samples will be obtained at autopsy.

Secondary Outcomes

  • Assess aspects associated with this procedure, including potential benefits and drawbacks(at autopsy)

Study Sites (3)

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