<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01698229</url>
  </required_header>
  <id_info>
    <org_study_id>1111012024</org_study_id>
    <nct_id>NCT01698229</nct_id>
  </id_info>
  <brief_title>Collection of Cerebrospinal Fluid in Healthy Children</brief_title>
  <official_title>Collection of Cerebrospinal Fluid in Healthy Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Weill Medical College of Cornell University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Weill Medical College of Cornell University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to obtain cerebrospinal fluid from healthy children already&#xD;
      undergoing a lumbar puncture procedure at New York Presbyterian Hospital, to act as healthy&#xD;
      controls when compared to children with late infantile neuronal ceroid lipofuscinosis&#xD;
      (LINCL), a fatal neurodegenerative disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      obtain cerebrospinal fluid from healthy children already undergoing a lumbar puncture&#xD;
      procedure at New York Presbyterian Hospital, to act as healthy controls when compared to&#xD;
      children with late infantile neuronal ceroid lipofuscinosis (LINCL), a fatal&#xD;
      neurodegenerative disease.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Study interest shifted&#xD;
  </why_stopped>
  <start_date>December 2011</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Cerebrospinal fluid (CSF)</measure>
    <time_frame>1 time point (once)</time_frame>
    <description>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.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">32</enrollment>
  <condition>Late Infantile Neuronal Ceroid Lipofuscinosis</condition>
  <condition>Batten Disease</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Group 1</intervention_name>
    <description>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.</description>
    <arm_group_label>Group 1</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      5 mL of cerebrospinal fluid (CSF) will be collected in this study at one time point.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects will be healthy controls (children ages 2 years to 8 years) undergoing a lumbar&#xD;
        puncture at New York Presbyterian Hospital, for clinical care purposes. They will be&#xD;
        inpatients and outpatients.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males and females, ages 2 yrs to 8 yrs&#xD;
&#xD;
          -  Children already undergoing a lumbar puncture procedure for clinical or diagnostic&#xD;
             purposes&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of any significant neurological diseases, as judged by the co-investigators&#xD;
&#xD;
          -  Presence of any significant medical conditions including cancer&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>8 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ronald G Crystal, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Weill Medical College of Cornell University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Weill Cornell Medical College / New York Presbyterian Hospital</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2016</verification_date>
  <study_first_submitted>August 15, 2012</study_first_submitted>
  <study_first_submitted_qc>September 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2012</study_first_posted>
  <last_update_submitted>May 3, 2016</last_update_submitted>
  <last_update_submitted_qc>May 3, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 4, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cerebrospinal fluid</keyword>
  <keyword>Lumbar puncture</keyword>
  <keyword>Spinal tap</keyword>
  <keyword>Late infantile neuronal ceroid lipofuscinosis</keyword>
  <keyword>Batten disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neuronal Ceroid-Lipofuscinoses</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01698229
org study id: 1111012024
nct id: NCT01698229
lead sponsor: 
has dmc: No
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.
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.
observational model: Case-Only
time perspective: Cross-Sectional
measure: Cerebrospinal fluid (CSF)
time frame: 1 time point (once)
description: 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.
arm group label: Group 1
description: 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.
intervention type: Other
intervention name: Group 1
description: 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.
arm group label: Group 1
5 mL of cerebrospinal fluid (CSF) will be collected in this study at one time point.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 2 Years
maximum age: 8 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ronald G Crystal, MD
role: Principal Investigator
affiliation: Weill Medical College of Cornell University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Neuronal Ceroid-Lipofuscinoses
sharing ipd: No