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OpenTrials
Completed

NCT Number: NCT01556178

Blood and Cerebrospinal Fluid for Pediatric Brain Tumor Research

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.

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Key information

Conditions

Hydrocephalus Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

1 year–21 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Memorial Hospital

Chicago, Illinois, 60618, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. levels of miRNAs in the blood and CSF

    Time frame: 2 yrs

Secondary outcomes

  1. Survivin and biologic markers levels in the CSF and blood

    Time frame: 2 yrs

Sponsors and collaborators

Lead sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

Other

Registry information

Official study title

Collection of Blood and Cerebrospinal Fluid for Pediatric Brain Tumor Research

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Mar 16, 2012
Registry last updated
Feb 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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