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

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00897858
• Other study ID #: CDR0000481330
• Secondary ID: PBTC-N08
• Status: Withdrawn
• Phase: N/A
• First received: May 9, 2009
• Last updated: April 18, 2013
• Start date: August 2006

Study information

• 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

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Pediatric Brain Tumor Consortium	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

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