Clinical trial · Observational

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

NCT00897858CI-TRIAL-00010090withdrawnClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Why stopped (as posted): 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 The PRS team doesn't delete studies once registered, so they recommended changing the status to Withdrawn

Summary

Brief summary (as posted)

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

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Brain and Central Nervous System Tumors	—	UNRESOLVED	—

Interventions

Interventions (0)

Data not yet available

No intervention recorded.

Design

Arms and outcomes

Arms (1)

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

Primary outcomes (3)

measure
Number of IRB approvals of the study
timeFrame
Within 120 days of study release
description
IRB approval will be used as a surrogate marker of support for this protocol.
measure
Number of patients with proteomic data received at the Operations and Biostatistics Center
timeFrame
12, 18, 24, and 30 months after 4th IRB approval
description
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.

Eligibility

Eligibility (as posted)

Sex: All
Maximum age: 21 Years

Show eligibility criteria text

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

References

Publications (0)

Data not yet available

No reference posted for this study.

Registry

Dates and enrollment

Start: Aug 1, 2006
Primary completion: Jan 1, 2014
Completion: —
First posted: May 12, 2009
Last update posted: Apr 19, 2013
Enrollment: 0 (actual)
Lead sponsor: Pediatric Brain Tumor Consortium NETWORK
Collaborators: National Cancer Institute (NCI)
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