Clinical Trial: Studying Cerebrospinal Fluid Proteins and Angiogenesis Proteins in Young Patients With Newly Diagnosed Central Nervous System Tumors

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Observational

Official Title: Evaluation of Cerebral Spinal Fluid (CSF) Proteome and Angiogenesis Proteins in Children With Newly Diagnosed Central Nervous System Tumors

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 Summary:

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.


Sponsor: Pediatric Brain Tumor Consortium

Current Primary Outcome:

  • 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.


Original Primary Outcome:

  • Feasibility of centrally collecting and processing high-quality cerebrospinal fluid samples for proteomic studies
  • Protein biomarker discovery


Current Secondary Outcome:

Original Secondary Outcome:

Information By: Pediatric Brain Tumor Consortium

Dates:
Date Received: May 9, 2009
Date Started: August 2006
Date Completion:
Last Updated: April 18, 2013
Last Verified: April 2013