Clinical trial NCT01556178: Blood and Cerebrospinal Fluid for Pediatric Brain Tumor Research
Official title: Collection of Blood and Cerebrospinal Fluid for Pediatric Brain Tumor Research
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hydrocephalus
Keywords: Hydrocephalus
Survivin
miRNA
Lead sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
Sponsor class: OTHER
First posted: 2012-03-16
Enrollment: 5
Sex: ALL
Minimum age (years): 1
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility 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.

Primary outcomes:
measure: levels of miRNAs in the blood and CSF
timeFrame: 2 yrs
Secondary outcomes:
measure: Survivin and biologic markers levels in the CSF and blood
timeFrame: 2 yrs
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Children's Memorial Hospital
state: Illinois
Study officials:
affiliation: Ann & Robert H Lurie Children's Hospital of Chicago
name: Rishi Lulla, MD
role: PRINCIPAL_INVESTIGATOR
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