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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 : March 28, 2019
Sponsor:
Information provided by (Responsible Party):
Javad Nazarian, Children's National Research Institute

Tracking Information
First Submitted Date April 19, 2010
First Posted Date April 20, 2010
Last Update Posted Date March 28, 2019
Study Start Date April 2010
Estimated Primary Completion Date April 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 19, 2010)
  • 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: April 19, 2010)
Assess aspects associated with specimen acquisition, including potential benefits and drawbacks [ Time Frame: 4 years ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Molecular Analysis of Samples From Patients With Diffuse Intrinsic Pontine Glioma and Brainstem Glioma
Official Title Molecular Analysis of Samples From Patients With Diffuse Intrinsic Pontine Glioma and Brainstem Glioma
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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Cerebrospinal fluid, serum, urine, brainstem tumor and constitutional tissue from patients with diffuse intrinsic pontine glioma or brainstem glioma will be collected.
Sampling Method Non-Probability Sample
Study Population Community sample
Condition
  • Diffuse Intrinsic Pontine Glioma
  • Brainstem Glioma
Intervention Not Provided
Study Groups/Cohorts 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 19, 2010)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 2030
Estimated Primary Completion Date April 2025   (Final data collection date for primary outcome measure)
Eligibility 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)
Sex/Gender
Sexes Eligible for Study: All
Ages up to 21 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Javad Nazarian, PhD 202-476-6022 JNazarian@cnmc.org
Contact: Madhuri Kambhampati, MS 202-476-5198 mkambhampati@childrensnational.org
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01106794
Other Study ID Numbers DIPG-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Javad Nazarian, Children's National Research Institute
Study Sponsor Children's National Research Institute
Collaborators Not Provided
Investigators
Principal Investigator: Javad Nazarian, PhD Children's National Research Institute
PRS Account Children's National Research Institute
Verification Date March 2019