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

NCT ID: NCT00897858

Last Updated: 2013-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2006-08-31

Brief Summary

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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

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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.

Conditions

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Brain and Central Nervous System Tumors

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Pediatric CNS tumor patients

Newly diagnosed pediatric patients with CNS tumor and no prior irradiation or chemotherapy

No interventions assigned to this group

Eligibility Criteria

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Inclusion 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
Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Pediatric Brain Tumor Consortium

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Brian R. Rood, MD

Role: STUDY_CHAIR

Children's National Research Institute

Locations

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Children's National Medical Center

Washington D.C., District of Columbia, United States

Site Status

Children's Memorial Hospital - Chicago

Chicago, Illinois, United States

Site Status

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

Duke Comprehensive Cancer Center

Durham, North Carolina, United States

Site Status

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

Texas Children's Cancer Center and Hematology Service at Texas Children's Hospital

Houston, Texas, United States

Site Status

Children's Hospital and Regional Medical Center - Seattle

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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PBTC-N08

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000481330

Identifier Type: -

Identifier Source: org_study_id

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