Studying Cerebrospinal Fluid Proteins and Angiogenesis Proteins in Young Patients With Newly Diagnosed Central Nervous System Tumors
|ClinicalTrials.gov Identifier: NCT00897858|
Recruitment Status : Withdrawn (This non-therapeutic study was registered in error. The PRS team doesn't delete studies once registered, so they recommended changing the status to Withdrawn)
First Posted : May 12, 2009
Last Update Posted : April 19, 2013
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.
|Condition or disease|
|Brain and Central Nervous System Tumors|
- 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.
|Study Type :||Observational|
|Actual Enrollment :||0 participants|
|Official Title:||Evaluation of Cerebral Spinal Fluid (CSF) Proteome and Angiogenesis Proteins in Children With Newly Diagnosed Central Nervous System Tumors|
|Study Start Date :||August 2006|
|Estimated Primary Completion Date :||January 2014|
Pediatric CNS tumor patients
Newly diagnosed pediatric patients with CNS tumor and no prior irradiation or chemotherapy
- Number of IRB approvals of the study [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00897858
|United States, District of Columbia|
|Children's National Medical Center|
|Washington, District of Columbia, United States, 20010-2970|
|United States, Illinois|
|Children's Memorial Hospital - Chicago|
|Chicago, Illinois, United States, 60614|
|United States, Massachusetts|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|United States, North Carolina|
|Duke Comprehensive Cancer Center|
|Durham, North Carolina, United States, 27710|
|United States, Pennsylvania|
|Children's Hospital of Philadelphia|
|Philadelphia, Pennsylvania, United States, 19104-4318|
|Children's Hospital of Pittsburgh|
|Pittsburgh, Pennsylvania, United States, 15213|
|United States, Texas|
|Texas Children's Cancer Center and Hematology Service at Texas Children's Hospital|
|Houston, Texas, United States, 77030-2399|
|United States, Washington|
|Children's Hospital and Regional Medical Center - Seattle|
|Seattle, Washington, United States, 98105|
|Study Chair:||Brian R. Rood, MD||Children's Research Institute|