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Clinical Trial Details — Status: Withdrawn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Status Withdrawn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Status Withdrawn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. completion date
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


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
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