Collection of Cerebrospinal Fluid in Healthy Children

NCT01698229 | Terminated

• 1 other identifier: 1111012024
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Late Infantile Neuronal Ceroid Lipofuscinosis; Batten Disease

Keywords

Cerebrospinal fluid; Lumbar puncture; Spinal tap; Late infantile neuronal ceroid lipofuscinosis; Batten disease

Outcome Measures

Primary Outcomes (1)

• Cerebrospinal fluid (CSF)

  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.

  1 time point (once)

Study Arms (1)

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

Interventions

Group 1 OTHER

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.

Group 1

Eligibility Criteria

• Age: 2 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

You may not qualify if:

• Presence of any significant neurological diseases, as judged by the co-investigators
• Presence of any significant medical conditions including cancer

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Medical College / New York Presbyterian Hospital

New York, New York, 10065, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

5 mL of cerebrospinal fluid (CSF) will be collected in this study at one time point.

MeSH Terms

Conditions

Neuronal Ceroid-Lipofuscinoses

Condition Hierarchy (Ancestors)

Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Nervous System Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lipidoses; Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Ronald G Crystal, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2012
• First Posted: October 2, 2012
• Study Start: December 1, 2011
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: May 4, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)