Blood and Cerebrospinal Fluid for Pediatric Brain Tumor Research

Sponsor
Ann & Robert H Lurie Children's Hospital of Chicago (Other)
Overall Status
Completed
CT.gov ID
NCT01556178
Collaborator
(none)
5
1
9
0.6

Study Details

Study Description

Brief Summary

In normal patients, blood and cerebrospinal fluid (CSF) contain circulating cells and other molecules such as proteins and nucleic acids. In patients with central nervous system (CNS) and other conditions, the levels of these molecules may be altered. In several other studies at our institution, the investigators are investigating such molecules in tumor specimens as well as the blood and cerebrospinal fluid of pediatric patients with CNS tumors. However, these levels are difficult to interpret without comparing them to levels in patients without CNS tumors. The investigators propose a study to collect small amounts of blood and cerebrospinal fluid from pediatric patients without CNS tumors who are undergoing a diagnostic or therapeutic neurosurgical procedure aimed at addressing altered CSF dynamics.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    5 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Collection of Blood and Cerebrospinal Fluid for Pediatric Brain Tumor Research
    Study Start Date :
    Jul 1, 2011
    Actual Primary Completion Date :
    Apr 1, 2012
    Actual Study Completion Date :
    Apr 1, 2012

    Arms and Interventions

    Arm Intervention/Treatment
    Children without central nervous system tumors

    Children without central nervous system tumors between the ages of 1 year and 21 years who are undergoing a neurosurgical procedure to address hydrocephalus

    Outcome Measures

    Primary Outcome Measures

    1. levels of miRNAs in the blood and CSF [2 yrs]

    Secondary Outcome Measures

    1. Survivin and biologic markers levels in the CSF and blood [2 yrs]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Year to 21 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Children without central nervous system tumors who are undergoing a neurosurgical procedure to address hydrocephalus during which CSF will be obtained

    • Between the ages of 1 year and 21 years

    • Patients must be having blood draws, lumbar punctures or CSF sampling from Ommaya reservoirs or VPS as part of routine clinical care.

    Exclusion Criteria:
    • Patients who do not require routine blood draws and/or CSF collection as part of their routine clinical care

    • Patients who are considered too ill to participate as determined by their treating physician

    • Patients with documented bacterial of viral infections of the CSF, brain parenchyma and/or neurosurgical devices and/or

    • Patients with suspected de-myelinating conditions

    • Patients who are pregnant or lactating.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Children's Memorial Hospital Chicago Illinois United States 60618

    Sponsors and Collaborators

    • Ann & Robert H Lurie Children's Hospital of Chicago

    Investigators

    • Principal Investigator: Rishi Lulla, MD, Ann & Robert H Lurie Children's Hospital of Chicago

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Rishi Lulla, Principal Investigator, Ann & Robert H Lurie Children's Hospital of Chicago
    ClinicalTrials.gov Identifier:
    NCT01556178
    Other Study ID Numbers:
    • 2011-14612
    First Posted:
    Mar 16, 2012
    Last Update Posted:
    Feb 5, 2016
    Last Verified:
    Feb 1, 2016
    Keywords provided by Rishi Lulla, Principal Investigator, Ann & Robert H Lurie Children's Hospital of Chicago
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 5, 2016