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

This study has been withdrawn prior to enrollment.
(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 The PRS team doesn't delete studies once registered, so they recommended changing the status to Withdrawn)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Pediatric Brain Tumor Consortium
ClinicalTrials.gov Identifier:
NCT00897858
First received: May 9, 2009
Last updated: April 18, 2013
Last verified: April 2013

May 9, 2009
April 18, 2013
August 2006
January 2014   (final data collection date for primary outcome measure)
  • Number of IRB approvals of the study [ Time Frame: Within 120 days of study release ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
  • Feasibility of centrally collecting and processing high-quality cerebrospinal fluid samples for proteomic studies [ Designated as safety issue: No ]
  • Protein biomarker discovery [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00897858 on ClinicalTrials.gov Archive Site
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Studying Cerebrospinal Fluid Proteins and Angiogenesis Proteins in Young Patients With Newly Diagnosed Central Nervous System Tumors
Evaluation of Cerebral Spinal Fluid (CSF) Proteome and Angiogenesis Proteins in Children With Newly Diagnosed Central Nervous System Tumors

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

The study population consists of newly diagnosed pediatric patients with a CNS tumor and no prior irradiation or chemotherapy. Cerebrospinal fluid (CSF) is withdrawn as part of initial diagnosis/staging, the administration of intrathecal therapy, or CSF diversion.

Brain and Central Nervous System Tumors
Not Provided
Pediatric CNS tumor patients
Newly diagnosed pediatric patients with CNS tumor and no prior irradiation or chemotherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
Not Provided
January 2014   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically confirmed CNS tumors of any of the following histologies:

    • Diffuse pontine gliomas*
    • Focal/infiltrative tumors, including any of the following:

      • High- and low-grade gliomas
      • Gangliogliomas
      • Ependymomas
      • Oligodendrogliomas
      • Craniopharyngioma
      • Dysembryoplastic neuroepithelial tumors
      • Other low-grade neoplasms
    • Optic pathway gliomas*
    • Seeding tumors, including any of the following:

      • Germ cell tumors (germinomas and nongerminomas)
      • Embryonal tumors, including any of the following:

        • Medulloblastoma
        • Pineoblastoma
        • Supratentorial primitive neuroectodermal tumors
        • Atypical teratoid/rhabdoid tumor
        • Other embryonal tumors NOTE: *Histological requirement waived
  • Newly diagnosed disease
  • Cerebrospinal fluid (CSF) obtained as part of CSF diversion, initial diagnosis/staging, or administration of intrathecal chemotherapy (at the initiation of postoperative therapy)

PATIENT CHARACTERISTICS:

  • Less than 22 years of age

PRIOR CONCURRENT THERAPY:

  • No prior radiotherapy or chemotherapy
  • Prior corticosteroids allowed
Both
up to 21 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00897858
CDR0000481330, PBTC-N08
No
Pediatric Brain Tumor Consortium
Pediatric Brain Tumor Consortium
National Cancer Institute (NCI)
Study Chair: Brian R. Rood, MD Children's Research Institute
Pediatric Brain Tumor Consortium
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP