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

Evaluation of Cerebral Spinal Fluid (CSF) Proteome and Angiogenesis Proteins in Children With Newly Diagnosed Central Nervous System Tumors

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00897858

Enrollment

Registered

2009-05-12

Start date

2006-08-31

Completion date

Unknown

Last updated

2013-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 21 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Number of IRB approvals of the study	Within 120 days of study release	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	12, 18, 24, and 30 months after 4th IRB approval	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	Pre-treatment	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.

Countries

United States

Outcome results