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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
Sponsor:
Information provided by (Responsible Party):
Javad Nazarian, Children's Research Institute

Study Description
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Brief Summary:
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 or disease
Diffuse Intrinsic Pontine Glioma Brainstem Glioma

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.

Study Design
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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

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U.S. FDA Resources

Groups and Cohorts
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Group/Cohort
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


Outcome Measures
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Primary Outcome Measures :
  1. Genome-wide expression patterns of RNA in tumor samples, normal brainstem tissue and cerebrospinal fluid using Affymetrix gene expression profiling [ Time Frame: 4 years ]
  2. Validation of results of the genome-wide analysis [ Time Frame: 4 years ]
  3. Proteomic profiling of tumor, normal brainstem tissue and cerebrospinal fluid [ Time Frame: 4 years ]
  4. Protein expression patterns as assessed by immunohistochemistry and western blot compared to normal brainstem tissue [ Time Frame: 4 years ]
  5. Genome-wide analysis of tumor samples and normal brainstem tissue [ Time Frame: 4 years ]
  6. 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.


Secondary Outcome Measures :
  1. Assess aspects associated with specimen acquisition, including potential benefits and drawbacks [ Time Frame: 4 years ]

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.

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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
Study Population
Community sample
Criteria

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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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


Contacts
Contact: Javad Nazarian, PhD 202-476-6022 JNazarian@cnmc.org
Contact: Madhuri Kambhampati, MS 202-476-5198 mkambhampati@childrensnational.org

Locations
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         
Sponsors and Collaborators
Children's Research Institute
Investigators
Principal Investigator: Javad Nazarian, PhD Children's Research Institute
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Children's National Medical Center  This link exits the ClinicalTrials.gov site

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