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NCT01698229 Clinical Trial

Collection of Cerebrospinal Fluid in Healthy Children

Batten Disease Clinical Trial

Official title:
Collection of Cerebrospinal Fluid in Healthy Children

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01698229
Other study ID # 1111012024
Secondary ID
Status Terminated
Phase N/A
First received August 15, 2012
Last updated May 3, 2016
Start date December 2011
Est. completion date December 2015

Study information
Verified date May 2016
Source Weill Medical College of Cornell University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Terminated
Enrollment 32
Est. completion date December 2015
Est. primary completion date December 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 2 Years to 8 Years
Eligibility 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

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
United States Weill Cornell Medical College / New York Presbyterian Hospital New York New York

Sponsors (1)
Lead Sponsor Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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) No
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