Not provided
Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| PBTC-N08 | Other Identifier | Pediatric Brain Tumor Consortium |
Not provided
Not provided
Not provided
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 The PRS team doesn't delete studies once registered, so they recommended changing the status to Withdrawn
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pediatric CNS tumor patients | Newly diagnosed pediatric patients with CNS tumor and no prior irradiation or chemotherapy |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
DISEASE CHARACTERISTICS:
Histologically confirmed CNS tumors of any of the following histologies:
Diffuse pontine gliomas*
Focal/infiltrative tumors, including any of the following:
Optic pathway gliomas*
Seeding tumors, including any of the following:
Germ cell tumors (germinomas and nongerminomas)
Embryonal tumors, including any of the following:
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:
PRIOR CONCURRENT THERAPY:
Not provided
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Brian R. Rood, MD | Children's National Research Institute | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010-2970 | United States | ||
Not provided
Not provided
Not provided
Not provided
| Children's Memorial Hospital - Chicago |
| Chicago |
| Illinois |
| 60614 |
| United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |
| Duke Comprehensive Cancer Center | Durham | North Carolina | 27710 | United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104-4318 | United States |
| Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
| Texas Children's Cancer Center and Hematology Service at Texas Children's Hospital | Houston | Texas | 77030-2399 | United States |
| Children's Hospital and Regional Medical Center - Seattle | Seattle | Washington | 98105 | United States |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D016545 | Choroid Plexus Neoplasms |
| D018335 | Rhabdoid Tumor |
| D001254 | Astrocytoma |
| ID | Term |
|---|---|
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009422 | Nervous System Diseases |
| D002551 | Cerebral Ventricle Neoplasms |
| D001932 | Brain Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D018193 | Neoplasms, Complex and Mixed |
| D009370 | Neoplasms by Histologic Type |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
Not provided
Not provided