Collection of Cerebrospinal Fluid in Healthy Children

This study has been terminated.
(Study interest shifted)
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT01698229
First received: August 15, 2012
Last updated: May 3, 2016
Last verified: May 2016
  Purpose
The purpose of this study is to obtain cerebrospinal fluid from healthy children already undergoing a lumbar puncture procedure at New York Presbyterian Hospital, to act as healthy controls when compared to children with late infantile neuronal ceroid lipofuscinosis (LINCL), a fatal neurodegenerative disease.

Condition Intervention
Late Infantile Neuronal Ceroid Lipofuscinosis
Batten Disease
Other: Group 1

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Collection of Cerebrospinal Fluid in Healthy Children

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • Cerebrospinal fluid (CSF) [ Time Frame: 1 time point (once) ] [ Designated as safety issue: No ]
    The primary study endpoint is the metabolic profiling of 32 samples of cerebrospinal fluid from healthy subjects, in comparison to 32 samples of CSF from children with LINCL, to determine whether there are biomarkers found in the cerebrospinal fluid that are associated with LINCL.


Biospecimen Retention:   Samples Without DNA
5 mL of cerebrospinal fluid (CSF) will be collected in this study at one time point.

Enrollment: 32
Study Start Date: December 2011
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1
Study cohort is comprised of healthy children, ages 2yrs - 8yrs, who are already undergoing a lumbar puncture procedure at New York Presbyterian Hospital for clinical or diagnostic purposes.
Other: Group 1
Collecting a small amount of cerebrospinal fluid (5 mL) from healthy children, ages 2 yrs - 8 yrs, who are already undergoing a lumbar puncture procedure at New York Presbyterian Hospital for clinical or diagnostic purposes.

Detailed Description:
obtain cerebrospinal fluid from healthy children already undergoing a lumbar puncture procedure at New York Presbyterian Hospital, to act as healthy controls when compared to children with late infantile neuronal ceroid lipofuscinosis (LINCL), a fatal neurodegenerative disease.
  Eligibility

Ages Eligible for Study:   2 Years to 8 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Subjects will be healthy controls (children ages 2 years to 8 years) undergoing a lumbar puncture at New York Presbyterian Hospital, for clinical care purposes. They will be inpatients and outpatients.
Criteria

Inclusion Criteria:

  • Males and females, ages 2 yrs to 8 yrs
  • Children already undergoing a lumbar puncture procedure for clinical or diagnostic purposes

Exclusion Criteria:

  • Presence of any significant neurological diseases, as judged by the co-investigators
  • Presence of any significant medical conditions including cancer
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01698229

Locations
United States, New York
Weill Cornell Medical College / New York Presbyterian Hospital
New York, New York, United States, 10065
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: Ronald G Crystal, MD Weill Medical College of Cornell University
  More Information

Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT01698229     History of Changes
Other Study ID Numbers: 1111012024 
Study First Received: August 15, 2012
Last Updated: May 3, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Weill Medical College of Cornell University:
Cerebrospinal fluid
Lumbar puncture
Spinal tap
Late infantile neuronal ceroid lipofuscinosis
Batten disease

Additional relevant MeSH terms:
Neuronal Ceroid-Lipofuscinoses
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Nervous System Diseases
Genetic Diseases, Inborn
Lipidoses
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on August 28, 2016