Collection of Cerebrospinal Fluid in Healthy Children

• Sponsor: Weill Medical College of Cornell University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01698229
• Collaborator: (none)
• Enrollment: 32
• Location: 1
• Duration (Months): 48
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Late Infantile Neuronal Ceroid Lipofuscinosis; Batten Disease	Other: Group 1

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 32 participants
• Observational Model: Case-Only
• Time Perspective: Cross-Sectional
• Official Title: Collection of Cerebrospinal Fluid in Healthy Children
• Study Start Date: Dec 1, 2011
• Actual Primary Completion Date: Dec 1, 2015
• Actual Study Completion Date: Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. Cerebrospinal fluid (CSF) [1 time point (once)]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Years to 8 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Weill Medical College of Cornell University
• ClinicalTrials.gov Identifier: NCT01698229
• Other Study ID Numbers: 1111012024
• First Posted: Oct 2, 2012
• Last Update Posted: May 4, 2016
• Last Verified: May 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• 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

Study Results

No Results Posted as of May 4, 2016