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


N/A
N/A
21 Years
Not Enrolling
Both
Brain and Central Nervous System Tumors

Thank you

Trial Information

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


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.

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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Number of IRB approvals of the study

Outcome Description:

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

Outcome Time Frame:

Within 120 days of study release

Safety Issue:

No

Principal Investigator

Brian R. Rood, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Children's Research Institute

Authority:

United States: Federal Government

Study ID:

CDR0000481330

NCT ID:

NCT00897858

Start Date:

August 2006

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • 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
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

Name

Location

Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania  19104
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Children's National Medical CenterWashington, District of Columbia  20010-2970
Children's Hospital of PittsburghPittsburgh, Pennsylvania  15213
Children's Hospital and Regional Medical Center - SeattleSeattle, Washington  98105
Children's Memorial Hospital - ChicagoChicago, Illinois  60614
Texas Children's Cancer Center and Hematology Service at Texas Children's HospitalHouston, Texas  77030-2399