Brain and Central Nervous System Tumors Clinical Trial
Official title:
Evaluation of Cerebral Spinal Fluid (CSF) Proteome and Angiogenesis Proteins in Children With Newly Diagnosed Central Nervous System Tumors
Verified date | April 2013 |
Source | Pediatric Brain Tumor Consortium |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Observational |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | |
Est. primary completion date | January 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 21 Years |
Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Dana-Farber Cancer Institute | Boston | Massachusetts |
United States | Children's Memorial Hospital - Chicago | Chicago | Illinois |
United States | Duke Comprehensive Cancer Center | Durham | North Carolina |
United States | Texas Children's Cancer Center and Hematology Service at Texas Children's Hospital | Houston | Texas |
United States | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania |
United States | Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania |
United States | Children's Hospital and Regional Medical Center - Seattle | Seattle | Washington |
United States | Children's National Medical Center | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Pediatric Brain Tumor Consortium | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Primary | 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 | No |
Primary | 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 | No |
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