Molecular Analysis of Samples From Patients With Diffuse Intrinsic Pontine Glioma and Brainstem Glioma
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Purpose
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.
| Condition |
|---|
|
Diffuse Intrinsic Pontine Glioma Brainstem Glioma |
| Study Type: | Observational |
| 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.
| Estimated Enrollment: | 100 |
| Study Start Date: | April 2010 |
| Estimated Study Completion Date: | April 2014 |
| Estimated Primary Completion Date: | April 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
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Patient samples
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
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Detailed Description:
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.
Eligibility| Ages Eligible for Study: | up to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Community sample
Inclusion Criteria:
- Patients of any age with clinical and radiologic diagnosis of diffuse intrinsic pontine glioma
- Patients with other high-grade gliomas originating in the brainstem
- Patients with focal gliomas (WHO grade I/II) of the brainstem
Exclusion Criteria:
- Patients with any type of infiltrative low grade (WHO grade I and 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)
Contacts and Locations| Contact: Javad Nazarian, PhD | 202-476-6022 | JNazarian@cnmcresearch.org |
| Contact: Jennifer P Perez, BA | 202-476-2761 | JPPerez@cnmc.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 |
More Information
Additional Information:
Publications:
| Responsible Party: | Javad Nazarian, Assistant Professor, Children's Research Institute |
| ClinicalTrials.gov Identifier: | NCT01106794 History of Changes |
| Other Study ID Numbers: | DIPG-1 |
| Study First Received: | April 19, 2010 |
| Last Updated: | April 26, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Children's Research Institute:
|
diffuse intrinsic pontine glioma DIPG childhood brainstem glioma |
pediatric brainstem glioma brainstem glioma BSG |
Additional relevant MeSH terms:
|
Glioma Pontine Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Astrocytoma |
ClinicalTrials.gov processed this record on May 16, 2013