Molecular Analysis of Samples From Patients With Diffuse Intrinsic Pontine Glioma and Brainstem Glioma

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Children's Research Institute
Sponsor:
Information provided by (Responsible Party):
Javad Nazarian, Children's Research Institute
ClinicalTrials.gov Identifier:
NCT01106794
First received: April 19, 2010
Last updated: November 18, 2013
Last verified: November 2013

April 19, 2010
November 18, 2013
April 2010
April 2014   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01106794 on ClinicalTrials.gov Archive Site
Assess aspects associated with specimen acquisition, including potential benefits and drawbacks [ Time Frame: 4 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Molecular Analysis of Samples From Patients With Diffuse Intrinsic Pontine Glioma and Brainstem Glioma
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
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.

Non-Probability Sample

Community sample

  • Diffuse Intrinsic Pontine Glioma
  • Brainstem Glioma
Not Provided
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
April 2014
April 2014   (final data collection date for primary outcome measure)

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)
Both
up to 21 Years
No
Contact: Javad Nazarian, PhD 202-476-6022 JNazarian@cnmcresearch.org
Contact: Madhuri Kambhampati, MS 202-476-5198 mkambhampati@childrensnational.org
United States
 
NCT01106794
DIPG-1
No
Javad Nazarian, Children's Research Institute
Children's Research Institute
Not Provided
Principal Investigator: Javad Nazarian, PhD Children's Research Institute
Children's Research Institute
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP