NCT01106794 · Children's National Research Institute
Molecular Analysis of Samples From Patients With Diffuse Intrinsic Pontine Glioma and Brainstem Glioma
What this study is about
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.
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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.
Primary outcome measures
Genome-wide expression patterns of RNA in tumor samples, normal brainstem tissue and cerebrospinal fluid using Affymetrix gene expression profiling
Time frame: 5 years
Collected tumor and normal samples will potentially be used for RNA genome-wide expression pattern profiling.
Validation of results of the genome-wide analysis
Time frame: 5 years
The molecular analysis done on collected samples will be validated through whole genome sequencing.
Proteomic profiling of tumor, normal brainstem tissue and cerebrospinal fluid
Time frame: 5 years
To obtain full characterization of collected samples, proteomic profiling will be done on tumor and normal samples collected.
Protein expression patterns as assessed by immunohistochemistry and western blot compared to normal brainstem tissue
Time frame: 5 years
Collected tumor and normal samples will have the immunochemistry and western blot compared to assess protein expression variation.
Genome-wide analysis of tumor samples and normal brainstem tissue
Time frame: 5 years
To obtain full characterization of collected samples, whole genome sequencing will be done on tumor and normal samples collected.
In vitro and in vivo molecular analysis of collected samples
Time frame: 5 years
Collected samples will potentially be used for in vitro analysis and generation of animal models of this tumor.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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)
Where
- Washington D.C., District of Columbia
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 20, 2024 · Source of record for eligibility and locations