Molecular Analysis of Samples From Patients With Diffuse Intrinsic Pontine Glioma and Brainstem Glioma
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ClinicalTrials.gov Identifier: NCT01106794 |
Recruitment Status
:
Recruiting
First Posted
: April 20, 2010
Last Update Posted
: January 16, 2018
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Condition or disease |
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Diffuse Intrinsic Pontine Glioma Brainstem Glioma |
Study Type : | Observational |
Estimated Enrollment : | 100 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Molecular Analysis of Samples From Patients With Diffuse Intrinsic Pontine Glioma and Brainstem Glioma |
Study Start Date : | April 2010 |
Estimated Primary Completion Date : | April 2025 |
Estimated Study Completion Date : | April 2030 |

Group/Cohort |
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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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- Genome-wide expression patterns of RNA in tumor samples, normal brainstem tissue and cerebrospinal fluid using Affymetrix gene expression profiling [ Time Frame: 4 years ]
- Validation of results of the genome-wide analysis [ Time Frame: 4 years ]
- Proteomic profiling of tumor, normal brainstem tissue and cerebrospinal fluid [ Time Frame: 4 years ]
- Protein expression patterns as assessed by immunohistochemistry and western blot compared to normal brainstem tissue [ Time Frame: 4 years ]
- Genome-wide analysis of tumor samples and normal brainstem tissue [ Time Frame: 4 years ]
- In vitro and in vivo molecular analysis of collected samples [ Time Frame: 4 years ]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 ]
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | up to 21 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability 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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01106794
Contact: Javad Nazarian, PhD | 202-476-6022 | JNazarian@cnmc.org | |
Contact: Madhuri Kambhampati, MS | 202-476-5198 | mkambhampati@childrensnational.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 |
Additional Information:
Publications of Results:
Other Publications:
Responsible Party: | Javad Nazarian, Associate Professor, Children's Research Institute |
ClinicalTrials.gov Identifier: | NCT01106794 History of Changes |
Other Study ID Numbers: |
DIPG-1 |
First Posted: | April 20, 2010 Key Record Dates |
Last Update Posted: | January 16, 2018 |
Last Verified: | January 2018 |
Keywords provided by Javad Nazarian, Children's Research Institute:
diffuse intrinsic pontine glioma DIPG childhood brainstem glioma |
pediatric brainstem glioma brainstem glioma BSG |
Additional relevant MeSH terms:
Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue |