Recruiting

Observational Study

Sponsor:

Children's National Research Institute

Code:

NCT01106794

Conditions

Diffuse Intrinsic Pontine Glioma

Brainstem Glioma

Eligibility Criteria

Sex: All

Age: 0 - 21

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Diffuse Intrinsic Pontine Glioma

Brainstem Glioma

Study ID

NCT01106794

Start date

Apr, 2010

Status verified date

Aug, 2024

Completion date

Apr, 2030

Anticipated

Primary completion date

Apr, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 21

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

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

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: 5 years ]
  • Validation of results of the genome-wide analysis [ Time Frame: 5 years ]
  • Proteomic profiling of tumor, normal brainstem tissue and cerebrospinal fluid [ Time Frame: 5 years ]
  • Protein expression patterns as assessed by immunohistochemistry and western blot compared to normal brainstem tissue [ Time Frame: 5 years ]
  • Genome-wide analysis of tumor samples and normal brainstem tissue [ Time Frame: 5 years ]
  • In vitro and in vivo molecular analysis of collected samples [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Javad Nazarian, PhD

202-476-6022JNazarian@cnmc.org

Caroline Kopsidas, BS

240-393-3359ckopsidas@childrensnational.org

Locations

Children's National Medical Center

Recruiting

Washington, District of Columbia, United States, 20010

Principal Investigator:

Javad Nazarian, PhD

More Information

Sponsor

Children's National Research Institute

Last update posted

Aug 20, 2024

Last verified

Aug, 2024

Keywords

  • diffuse intrinsic pontine glioma
  • DIPG
  • childhood brainstem glioma
  • pediatric brainstem glioma
  • brainstem glioma
  • BSG

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Children's National Research Institute on 2024-08-20.