Molecular Analysis of Samples From Patients With Diffuse Intrinsic Pontine Glioma and Brainstem Glioma
The purpose of this study is to prospectively collect specimens from pediatric patients with diffuse intrinsic pontine glioma or brainstem glioma, either during therapy or at autopsy, in order to characterize the molecular abnormalities of this tumor.
Diffuse Intrinsic Pontine Glioma
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Molecular Analysis of Samples From Patients With Diffuse Intrinsic Pontine Glioma and Brainstem Glioma|
- Genome-wide expression patterns of RNA in tumor samples, normal brainstem tissue and cerebrospinal fluid using Affymetrix gene expression profiling [ Time Frame: 4 years ] [ Designated as safety issue: No ]
- Validation of results of the genome-wide analysis [ Time Frame: 4 years ] [ Designated as safety issue: No ]
- Proteomic profiling of tumor, normal brainstem tissue and cerebrospinal fluid [ Time Frame: 4 years ] [ Designated as safety issue: No ]
- Protein expression patterns as assessed by immunohistochemistry and western blot compared to normal brainstem tissue [ Time Frame: 4 years ] [ Designated as safety issue: No ]
- Genome-wide analysis of tumor samples and normal brainstem tissue [ Time Frame: 4 years ] [ Designated as safety issue: No ]
- In vitro and in vivo molecular analysis of collected samples [ Time Frame: 4 years ] [ Designated as safety issue: No ]Collected samples will potentially be used for in vitro analysis and generation of animal models of this tumor.
- Assess aspects associated with specimen acquisition, including potential benefits and drawbacks [ Time Frame: 4 years ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Cerebrospinal fluid, serum, urine, brainstem tumor and constitutional tissue from patients with diffuse intrinsic pontine glioma or brainstem glioma will be collected.
|Study Start Date:||April 2010|
|Estimated Study Completion Date:||April 2020|
|Estimated Primary Completion Date:||April 2016 (Final data collection date for primary outcome measure)|
Fresh-frozen and fixed tumor samples, correspondent normal brain tissue samples, cerebrospinal fluid, urine, and serum samples from patients affected with diffuse intrinsic pontine glioma or brainstem glioma
High grade diffuse intrinsic pontine glioma (DIPG) accounts for approximately 80% of pediatric brainstem tumors and 10% of pediatric brain tumors, and is the most lethal form of brainstem gliomas in children. There is currently no effective therapy to treat these tumors. We hypothesize that this tumor exhibits unique molecular abnormalities leading to altered RNA and protein expression. The aim of this trial is to collect specimens from pediatric patients with diffuse intrinsic pontine glioma including serum, cerebrospinal fluid, urine, brain tumor and other constitutional tissue, during therapy and/or at autopsy. Our goal is to study this tissue to characterize the genetic abnormalities that lead to tumor formation in order to identify key molecules as biomarkers which we can target to design and test new and more effective treatments.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01106794
|Contact: Javad Nazarian, PhD||202-476-6022||JNazarian@cnmc.org|
|Contact: Madhuri Kambhampati, MSfirstname.lastname@example.org|
|United States, District of Columbia|
|Children's National Medical Center||Recruiting|
|Washington, District of Columbia, United States, 20010|
|Principal Investigator: Javad Nazarian, PhD|
|Sub-Investigator: Roger Packer, MD|
|Sub-Investigator: Suresh Magge, MD|
|Sub-Investigator: Amanda L Muhs, MD|
|Principal Investigator:||Javad Nazarian, PhD||Children's Research Institute|