Molecular Analysis of Samples From Patients With Diffuse Intrinsic Pontine Glioma and Brainstem Glioma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 21
SponsorChildren's National Research Institute
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial population
Community sample
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
100 Participants
are grouped into 1 trial groupGroup A: Patient samples
Trial outcomes
Primary outcomes
1
Genome-wide expression patterns of RNA in tumor samples, normal brainstem tissue and cerebrospinal fluid using Affymetrix gene expression profiling
Collected tumor and normal samples will potentially be used for RNA genome-wide expression pattern profiling.
Time frame
5 years2
Validation of results of the genome-wide analysis
The molecular analysis done on collected samples will be validated through whole genome sequencing.
Time frame
5 years3
Proteomic profiling of tumor, normal brainstem tissue and cerebrospinal fluid
To obtain full characterization of collected samples, proteomic profiling will be done on tumor and normal samples collected.
Time frame
5 years4
Protein expression patterns as assessed by immunohistochemistry and western blot compared to normal brainstem tissue
Collected tumor and normal samples will have the immunochemistry and western blot compared to assess protein expression variation.
Time frame
5 yearsSecondary outcomes
1
Assess aspects associated with specimen acquisition, including potential benefits and drawbacks
In an effort to continue to draw knowledge from samples collected, potential benefits and drawbacks from specimen acquisition will be continuously accessed.
Time frame
5 yearsSponsors and contacts
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Source ClinicalTrials.gov