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Blood and Cerebrospinal Fluid for Pediatric Brain Tumor Research

This study is currently recruiting participants.
Verified March 2012 by Ann & Robert H Lurie Children's Hospital of Chicago
Sponsor:
Information provided by (Responsible Party):
Rishi Lulla, Children's Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01556178
First received: February 24, 2012
Last updated: March 15, 2012
Last verified: March 2012
History of Changes
  Purpose

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
Hydrocephalus

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Collection of Blood and Cerebrospinal Fluid for Pediatric Brain Tumor Research

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ann & Robert H Lurie Children's Hospital of Chicago:

Primary Outcome Measures:
  • levels of miRNAs in the blood and CSF [ Time Frame: 2 yrs ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Survivin and biologic markers levels in the CSF and blood [ Time Frame: 2 yrs ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

whole blood and cerebrospinal fluid


Estimated Enrollment: 40
Study Start Date: July 2011
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Ages Eligible for Study:   1 Year to 21 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01556178

Contacts
Contact: Rishi Lulla, MD 773.880.4562 rlulla@childrensmemorial.org
Contact: Carrie Kempler, MPH 773.883.6186 ckempler@childrensmemorial.org

Locations
United States, Illinois
Children's Memorial Hospital Recruiting
Chicago, Illinois, United States, 60618
Contact: Carrie Kempler, MPH     773-883-6186     ckempler@childrensmemorial.org    
Contact: Maya Nikin     773.880.8171     mnikin@childrensmemorial.org    
Principal Investigator: Rishi Lulla, MD            
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

Publications:

Responsible Party: Rishi Lulla, Principal Investigator, Children's Memorial Hospital
ClinicalTrials.gov Identifier: NCT01556178     History of Changes
Other Study ID Numbers: 2011-14612
Study First Received: February 24, 2012
Last Updated: March 15, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by 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
Intracranial Hypertension

ClinicalTrials.gov processed this record on May 16, 2013