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Blood and Cerebrospinal Fluid for Pediatric Brain Tumor Research

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ClinicalTrials.gov Identifier: NCT01556178
Recruitment Status : Completed
First Posted : March 16, 2012
Last Update Posted : February 5, 2016
Sponsor:
Information provided by (Responsible Party):
Rishi Lulla, Ann & Robert H Lurie Children's Hospital of Chicago

Study Description
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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
Hydrocephalus

Study Design
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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 : July 2011
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

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Groups and Cohorts
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Group/Cohort
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
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Primary Outcome Measures :
  1. levels of miRNAs in the blood and CSF [ Time Frame: 2 yrs ]

Secondary Outcome Measures :
  1. Survivin and biologic markers levels in the CSF and blood [ Time Frame: 2 yrs ]

Biospecimen Retention:   Samples Without DNA
whole blood and cerebrospinal fluid

Eligibility Criteria
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Ages Eligible for Study:   1 Year to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All children without central nervous system tumors between the ages of 1 year and 21 years who are undergoing a neurosurgical procedure to address hydrocephalus during which CSF will be obtained will be considered
Criteria

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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01556178


Locations
United States, Illinois
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
More Information
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Publications:

Responsible Party: Rishi Lulla, Principal Investigator, Ann & Robert H Lurie Children's Hospital of Chicago
ClinicalTrials.gov Identifier: NCT01556178     History of Changes
Other Study ID Numbers: 2011-14612
First Posted: March 16, 2012    Key Record Dates
Last Update Posted: February 5, 2016
Last Verified: February 2016

Keywords provided by Rishi Lulla, Ann & Robert H Lurie Children's Hospital of Chicago:
Hydrocephalus
Survivin
miRNA

Additional relevant MeSH terms:
Brain Neoplasms
Hydrocephalus
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
 Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases