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

Sponsor:	Pediatric Brain Tumor Consortium
Collaborator:	National Cancer Institute (NCI)
Information provided by:	Pediatric Brain Tumor Consortium
ClinicalTrials.gov Identifier:	NCT00897858

Purpose

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
Brain and Central Nervous System Tumors

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Evaluation of Cerebral Spinal Fluid (CSF) Proteome and Angiogenesis Proteins in Children With Newly Diagnosed Central Nervous System Tumors

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by Pediatric Brain Tumor Consortium:

Primary Outcome Measures:

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.

Estimated Enrollment:	99
Study Start Date:	August 2006
Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts
Pediatric CNS tumor patients Newly diagnosed pediatric patients with CNS tumor and no prior irradiation or chemotherapy

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.

Eligibility

Ages Eligible for Study:	up to 21 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

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.

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00897858

Locations

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

Sponsors and Collaborators

Pediatric Brain Tumor Consortium

National Cancer Institute (NCI)

Investigators

Study Chair:

Brian R. Rood, MD

Children's Research Institute

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	James M. Boyett, Executive Director PBTC Operations and Biostatistics Center, Pediatric Brain Tumor Consortium
ClinicalTrials.gov Identifier:	NCT00897858 History of Changes
Other Study ID Numbers:	CDR0000481330, PBTC-N08
Study First Received:	May 9, 2009
Last Updated:	August 31, 2010
Health Authority:	United States: Federal Government

Keywords provided by Pediatric Brain Tumor Consortium:

childhood central nervous system germ cell tumor
childhood choroid plexus tumor
childhood grade I meningioma
childhood grade II meningioma
childhood grade III meningioma
childhood atypical teratoid/rhabdoid tumor
untreated childhood visual pathway glioma
childhood infratentorial ependymoma
childhood supratentorial ependymoma
newly diagnosed childhood ependymoma
childhood craniopharyngioma
untreated childhood medulloblastoma

untreated childhood cerebellar astrocytoma
untreated childhood supratentorial primitive neuroectodermal tumor
untreated childhood brain stem glioma
untreated childhood visual pathway and hypothalamic glioma
childhood high-grade cerebral astrocytoma
childhood low-grade cerebral astrocytoma
childhood central nervous system choriocarcinoma
childhood central nervous system embryonal tumor
childhood central nervous system germinoma
childhood central nervous system mixed germ cell tumor
childhood central nervous system teratoma
childhood central nervous system yolk sac tumor

Additional relevant MeSH terms:

Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Nervous System Diseases

ClinicalTrials.gov processed this record on February 09, 2012