<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/NCT03775447</url>
  </required_header>
  <id_info>
    <org_study_id>ECV-003</org_study_id>
    <nct_id>NCT03775447</nct_id>
  </id_info>
  <brief_title>Fox BioNet Project: ECV-003</brief_title>
  <official_title>FoxBioNet: ECV (Extracellular Vesicle) 003</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Michael J. Fox Foundation for Parkinson's Research</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University Health Network, Toronto</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Indiana University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Rochester</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Michael J. Fox Foundation for Parkinson's Research</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this study is to optimize pre-analytical cerebrospinal fluid (CSF) extracellular&#xD;
      vesicle isolation protocols for increasing the detection of LRRK2 activity in human CSF&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Specific aims to accomplish this objective are:&#xD;
&#xD;
      PRIMARY OBJECTIVES:&#xD;
&#xD;
        -  To evaluate a series of extracellular vesicle isolation methods for their ability to&#xD;
           enrich for LRRK2 and increase the detection of LRRK2 in CSF samples.&#xD;
&#xD;
        -  To compare the measurements of LRRK2, p1292 LRRK2, Rabs and pRabs from the ECVs isolated&#xD;
           using each method.&#xD;
&#xD;
        -  To assess the inter-lab reliability of each method&#xD;
&#xD;
      SECONDARY OBJECTIVES&#xD;
&#xD;
        -  To assess the ability of the network of sites to efficiently conduct a study involving&#xD;
           biosample collection for PD research. Efficiency will be assessed using measures of the&#xD;
           time taken to meet specific milestones within the study&#xD;
&#xD;
        -  To assess the ability of the network to collect high quality biospecimens adhering to&#xD;
           agreed-upon protocols.&#xD;
&#xD;
        -  To gauge the willingness of participants to participate in subsequent Fox BioNet studies&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 23, 2019</start_date>
  <completion_date type="Actual">December 18, 2019</completion_date>
  <primary_completion_date type="Actual">December 18, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>degree of LRRK2 enrichment achieved. The measure will vary depending on the method of LRRK2 enrichment used</measure>
    <time_frame>1 year</time_frame>
    <description>For methods involving immunoprecipitation: Increase in peptide spectral matches on mass spectrometry For methods amenable to antibody-based detection: increase in LRRK2 intensity on Western blotting (arbitrary units).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Power analysis to guide future research</measure>
    <time_frame>1 year</time_frame>
    <description>Pilot data to enable calculations for power analysis to guide future research studies for the primary outcomes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time from IRB submission to approval by central IRB</measure>
    <time_frame>3 months</time_frame>
    <description>Time from IRB submission to approval by central IRB</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time from central IRB approval to site approval</measure>
    <time_frame>3 months</time_frame>
    <description>Time from central IRB approval to site approval (for those sites requiring administrative review)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time from site selection to contract full execution</measure>
    <time_frame>4 months</time_frame>
    <description>Time from site selection to contract full execution</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Completion of Recruitment</measure>
    <time_frame>6 months</time_frame>
    <description>Time from site activation to completion of recruitment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of samples conforming to collection</measure>
    <time_frame>6 months</time_frame>
    <description>Proportion of samples conforming to collection, processing and shipping protocols.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Retention</measure>
    <time_frame>1 year</time_frame>
    <description>Proportion of participants agreeing to be contacted for future Fox BioNet protocols</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">38</enrollment>
  <condition>Parkinson Disease</condition>
  <arm_group>
    <arm_group_label>Parkinson's Disease Patients</arm_group_label>
    <description>A diagnosis of Parkinson's disease in the opinion of the enrolling investigator&#xD;
Disease duration: any&#xD;
Male or female age 18 years or older at time of PD diagnosis.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy Control (HC) Subjects</arm_group_label>
    <description>• Male or female age 18 years or older at Screening.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Lumbar Puncture</intervention_name>
    <description>Lumbar Puncture for collection of Cerebrospinal Fluids</description>
    <arm_group_label>Healthy Control (HC) Subjects</arm_group_label>
    <arm_group_label>Parkinson's Disease Patients</arm_group_label>
    <other_name>Biofluid Samplings: Blood</other_name>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Cerebro-Spinal Fluids&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Approximately 36 subjects will be enrolled to participate in this study, a combination of&#xD;
        Parkinson Disease (PD) (any stage) and Healthy Controls in no specified proportion.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Parkinson's Disease Patients:&#xD;
&#xD;
          -  A diagnosis of Parkinson's disease in the opinion of the enrolling investigator&#xD;
&#xD;
          -  Disease duration: any&#xD;
&#xD;
          -  Male or female age 18 years or older at time of PD diagnosis.&#xD;
&#xD;
        Healthy Controls:&#xD;
&#xD;
        •Male or female age 18 years or older at Screening.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Parkinson's Disease Patients:&#xD;
&#xD;
          -  Inability to provide informed consent&#xD;
&#xD;
          -  Current treatment with anticoagulants (e.g., coumadin, heparin) that might preclude&#xD;
             safe completion of the lumbar puncture.&#xD;
&#xD;
          -  Condition that precludes the safe performance of routine lumbar puncture, such as&#xD;
             prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant&#xD;
             coagulopathy or thrombocytopenia.&#xD;
&#xD;
          -  Participation in a blinded clinical trial of any kind or an unblinded trial of an&#xD;
             investigational product that is not currently approved for use in humans.&#xD;
&#xD;
        Healthy Controls:&#xD;
&#xD;
          -  Inability to provide informed consent&#xD;
&#xD;
          -  Current treatment with anticoagulants (e.g., coumadin, heparin) that might preclude&#xD;
             safe completion of the lumbar puncture.&#xD;
&#xD;
          -  Condition that precludes the safe performance of routine lumbar puncture, such as&#xD;
             prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant&#xD;
             coagulopathy or thrombocytopenia.&#xD;
&#xD;
          -  Participation in a blinded clinical trial of any kind or an unblinded trial of an&#xD;
             investigational product that is not currently approved for use in humans.&#xD;
&#xD;
          -  Currently pregnant (female participants)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Northwestern University</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oregon Health and Sciences University</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>November 20, 2018</study_first_submitted>
  <study_first_submitted_qc>December 12, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 14, 2018</study_first_posted>
  <last_update_submitted>August 31, 2021</last_update_submitted>
  <last_update_submitted_qc>August 31, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Health Network, Toronto</investigator_affiliation>
    <investigator_full_name>Connie Marras</investigator_full_name>
    <investigator_title>Neurologist at Toronto Western Hospital Movement Disorders Centre</investigator_title>
  </responsible_party>
  <keyword>Parkinson's Disease</keyword>
  <keyword>Biomarker</keyword>
  <keyword>LRRK2</keyword>
  <keyword>CSF</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</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/NCT03775447
org study id: ECV-003
nct id: NCT03775447
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The goal of this study is to optimize pre-analytical cerebrospinal fluid (CSF) extracellular
      vesicle isolation protocols for increasing the detection of LRRK2 activity in human CSF
Specific aims to accomplish this objective are:

      PRIMARY OBJECTIVES:

        -  To evaluate a series of extracellular vesicle isolation methods for their ability to
           enrich for LRRK2 and increase the detection of LRRK2 in CSF samples.

        -  To compare the measurements of LRRK2, p1292 LRRK2, Rabs and pRabs from the ECVs isolated
           using each method.

        -  To assess the inter-lab reliability of each method

      SECONDARY OBJECTIVES

        -  To assess the ability of the network of sites to efficiently conduct a study involving
           biosample collection for PD research. Efficiency will be assessed using measures of the
           time taken to meet specific milestones within the study

        -  To assess the ability of the network to collect high quality biospecimens adhering to
           agreed-upon protocols.

        -  To gauge the willingness of participants to participate in subsequent Fox BioNet studies
observational model: Case-Control
time perspective: Cross-Sectional
measure: degree of LRRK2 enrichment achieved. The measure will vary depending on the method of LRRK2 enrichment used
time frame: 1 year
description: For methods involving immunoprecipitation: Increase in peptide spectral matches on mass spectrometry For methods amenable to antibody-based detection: increase in LRRK2 intensity on Western blotting (arbitrary units).
measure: Power analysis to guide future research
time frame: 1 year
description: Pilot data to enable calculations for power analysis to guide future research studies for the primary outcomes
measure: Time from IRB submission to approval by central IRB
time frame: 3 months
description: Time from IRB submission to approval by central IRB
measure: Time from central IRB approval to site approval
time frame: 3 months
description: Time from central IRB approval to site approval (for those sites requiring administrative review)
measure: Time from site selection to contract full execution
time frame: 4 months
description: Time from site selection to contract full execution
measure: Completion of Recruitment
time frame: 6 months
description: Time from site activation to completion of recruitment.
measure: Proportion of samples conforming to collection
time frame: 6 months
description: Proportion of samples conforming to collection, processing and shipping protocols.
measure: Retention
time frame: 1 year
description: Proportion of participants agreeing to be contacted for future Fox BioNet protocols
arm group label: Parkinson's Disease Patients
description: A diagnosis of Parkinson's disease in the opinion of the enrolling investigator
Disease duration: any
Male or female age 18 years or older at time of PD diagnosis.
arm group label: Healthy Control (HC) Subjects
description: • Male or female age 18 years or older at Screening.
intervention type: Procedure
intervention name: Lumbar Puncture
description: Lumbar Puncture for collection of Cerebrospinal Fluids
arm group label: Healthy Control (HC) Subjects
arm group label: Parkinson's Disease Patients
other name: Biofluid Samplings: Blood
Cerebro-Spinal Fluids
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University Health Network, Toronto
investigator full name: Connie Marras
investigator title: Neurologist at Toronto Western Hospital Movement Disorders Centre
mesh term: Parkinson Disease
sharing ipd: No