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

NCT00897858 | Withdrawn

• 2 other identifiers: CDR0000481330PBTC-N08
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 8

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.

Conditions

Brain and Central Nervous System Tumors

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Number of IRB approvals of the study

  IRB approval will be used as a surrogate marker of support for this protocol.

  Within 120 days of study release

• Number of patients with proteomic data received at the Operations and Biostatistics Center

  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.

  12, 18, 24, and 30 months after 4th IRB approval

• Number of differentially expressed biomarker proteins

  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.

  Pre-treatment

Study Arms (1)

Pediatric CNS tumor patients

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

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Pediatric Brain Tumor Consortium: lead
• National Cancer Institute (NCI): collaborator

Study Sites (8)

Children's National Medical Center

Washington D.C., District of Columbia, 20010-2970, United States

Location

Children's Memorial Hospital - Chicago

Chicago, Illinois, 60614, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104-4318, United States

Location

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

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

Houston, Texas, 77030-2399, United States

Location

Children's Hospital and Regional Medical Center - Seattle

Seattle, Washington, 98105, United States

Location

MeSH Terms

Conditions

Central Nervous System Neoplasms; Choroid Plexus Neoplasms; Rhabdoid Tumor; Astrocytoma

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Cerebral Ventricle Neoplasms; Brain Neoplasms; Brain Diseases; Central Nervous System Diseases; Neoplasms, Complex and Mixed; Neoplasms by Histologic Type; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Brian R. Rood, MD

  Children's National Research Institute

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2009
• First Posted: May 12, 2009
• Study Start: August 1, 2006
• Primary Completion: January 1, 2014
• Last Updated: April 19, 2013

Record last verified: 2013-04

Locations

US (8)