Studying Cerebrospinal Fluid Proteins and Angiogenesis Proteins in Young Patients With Newly Diagnosed Central Nervous System Tumors
- Conditions
- Brain and Central Nervous System Tumors
- Registration Number
- NCT00897858
- Lead Sponsor
- Pediatric Brain Tumor Consortium
- Brief Summary
RATIONALE: Studying samples of cerebrospinal fluid from patients with cancer in the laboratory may help doctors identify biomarkers related to cancer.
PURPOSE: This laboratory study is studying cerebrospinal fluid proteins and angiogenesis proteins in young patients with newly diagnosed central nervous system tumors.
- Detailed Description
OBJECTIVES:
Primary
* Investigate the feasibility of centrally collecting and processing high-quality cerebrospinal fluid (CSF) samples from pediatric patients with newly diagnosed central nervous system tumors for proteomic studies.
* Identify protein markers that might indicate the presence of a brain tumor using CSF samples collected from these patients.
OUTLINE: This is a multicenter study.
Patients undergo cerebrospinal fluid (CSF) collection from any or all of the following 5 sites: lumbar, cervical, ommaya, intra-operative (ventricular, cisternal), and/or external ventricular drain. CSF is obtained within 8 weeks of diagnosis but prior to (or concurrent with) the initiation of any post-operative therapy (excluding corticosteroids).
CSF samples are examined for proteomic biomarkers by 2D gel electrophoresis, low-mass fingerprinting, and stable isotope labeling.
PROJECTED ACCRUAL: A total of 99 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of IRB approvals of the study Within 120 days of study release IRB approval will be used as a surrogate marker of support for this protocol.
Number of patients with proteomic data received at the Operations and Biostatistics Center 12, 18, 24, and 30 months after 4th IRB approval Feasibility implies registering patients, submitting samples for proteomic investigation, and successfully analyzing the data at the lab in a timely fashion. The number of patients with proteomic data received at the PBTC Operations and Biostatistics Center will be assessed at 12, 18, 24, and 30 months after the 4th institution receives IRB approval for the study.
Number of differentially expressed biomarker proteins Pre-treatment Unsupervised proteomic profiling will be done on the CSF samples obtained pre-treatment in order to identify proteins that differ between pediatric brain tumor patients and a banked set of pediatric control "normal" samples.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (8)
Children's Hospital and Regional Medical Center - Seattle
🇺🇸Seattle, Washington, United States
Children's National Medical Center
🇺🇸Washington, District of Columbia, United States
Children's Memorial Hospital - Chicago
🇺🇸Chicago, Illinois, United States
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Texas Children's Cancer Center and Hematology Service at Texas Children's Hospital
🇺🇸Houston, Texas, United States
Children's Hospital of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States