<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/NCT04473573</url>
  </required_header>
  <id_info>
    <org_study_id>VNV-00227</org_study_id>
    <nct_id>NCT04473573</nct_id>
  </id_info>
  <brief_title>Spartan Cube CYP2C19 Inter Laboratory Reproducibilty Study</brief_title>
  <official_title>Spartan Cube CYP2C19 Inter Laboratory Reproducibility Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Spartan Bioscience Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Children's Hospital of Eastern Ontario</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Ottawa Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The University of Ottawa Heart Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Spartan Bioscience Inc.</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study verifies that the Spartan Cube CYP2C19 System generates reproducible results under&#xD;
      multi-variant conditions including test site (three different test sites), operators (two&#xD;
      operators per site), testing days (five non-consecutive days per site), and test kit lot&#xD;
      (three different lots).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The reproducibility study (VNV-00227) is aimed at assessing the performance of the Spartan&#xD;
      Cube CYP2C19 product under multi-variant conditions that include test site, operators,&#xD;
      testing days, and reagent lots. The sections below address how these variables were tested.&#xD;
&#xD;
      This study will be performed by a total of six operators at three test sites. At each site,&#xD;
      two operators will conduct buccal sample collection and analysis. Operators include&#xD;
      individuals who are technologists, technicians, and/or nurses. The buccal samples will be&#xD;
      loaded in the Cube within one hour after buccal swab collection. Furthermore, results will be&#xD;
      generated using multiple platforms (Spartan Cube, computer, and printer) and the same&#xD;
      platforms will be used at each site. At each site, a total of 64 (8 subjects/operator x 2&#xD;
      operators x 2 sessions x 2 sub-sessions (replicates)) tests will be run on five&#xD;
      non-consecutive days. Each day includes 2 sessions and 2 sub-sessions (total 4 collection&#xD;
      times) in which samples will be collected. Test subject to platform pairing is not required,&#xD;
      results will be generated on one of the platforms per session. This means that each site will&#xD;
      generate a total of 320(64 obs./day x 5 days) results over the entire duration of the study.&#xD;
&#xD;
      To determine lot-to-lot reproducibility of test kits, three different lots will be evaluated.&#xD;
      For this, two lots will be tested at each site. Each operator will use two lots per session&#xD;
      on each testing day. Each replicate only includes a single lot of test kits.&#xD;
&#xD;
      All results generated by the Spartan Cube CYP2C19 System will be compared with the&#xD;
      bi-directional sequencing results.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 31, 2019</start_date>
  <completion_date type="Actual">March 17, 2020</completion_date>
  <primary_completion_date type="Actual">March 17, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>All subjects receive the same number and type of test for the duration of the study.</intervention_model_description>
    <primary_purpose>Screening</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>Bi-directional sequencing results will not be shard with the participants, operators or Principal investigators.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>% Agreement of test results generated on the Spartan Cube CYP2C19 System and bidirectional sequencing</measure>
    <time_frame>Through study completion; anticipated to be less than 6 months</time_frame>
    <description>Determine % agreement across all tests conducted and bi-directional sequencing results</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>Genotyping Techniques</condition>
  <arm_group>
    <arm_group_label>Lot to Lot Reproducibility</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The purpose of this arm is to provide evidence to support that each lot of manufactured reagents for the Spartan Cube CYP2C19 Test produce the same result. Each participant, over the course of the study at the various sites, will be tested using 3 different lots of manufactured Spartan CYP2C19 Test Kits.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Site to Site Reproducibility</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The purpose of this arm was to provide supporting evidence that showed the same samples (subjects), when tested at different locations, produce the same result.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Operator Reproducibility</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The purpose of this arm was to provide supporting evidence that showed the same samples (subjects), when collected and tested by different operators, produce the same result.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Spartan Cube CYP2C19 System</intervention_name>
    <description>Using buccal material, determine the genotype of the *2, *3 and *17 SNPs of the CYP2C19 gene on the Spartan Cube CYP2C19 System.</description>
    <arm_group_label>Lot to Lot Reproducibility</arm_group_label>
    <arm_group_label>Operator Reproducibility</arm_group_label>
    <arm_group_label>Site to Site Reproducibility</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  available for travel to three different sites, on 5 non-consecutive days.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  none&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shaimaa Ahmed, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Spartan Bioscience</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Children's Hospital of Eastern Ontario</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1H 8L6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ottawa Hospital Research Institute</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1H 8L6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Univeristy of Ottawa Heart Institute</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1Y4W7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 13, 2020</study_first_submitted>
  <study_first_submitted_qc>July 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 16, 2020</study_first_posted>
  <last_update_submitted>July 15, 2020</last_update_submitted>
  <last_update_submitted_qc>July 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Reproducibility of Results</keyword>
  <keyword>CYP2C19</keyword>
  <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/NCT04473573
org study id: VNV-00227
nct id: NCT04473573
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The study verifies that the Spartan Cube CYP2C19 System generates reproducible results under
      multi-variant conditions including test site (three different test sites), operators (two
      operators per site), testing days (five non-consecutive days per site), and test kit lot
      (three different lots).
The reproducibility study (VNV-00227) is aimed at assessing the performance of the Spartan
      Cube CYP2C19 product under multi-variant conditions that include test site, operators,
      testing days, and reagent lots. The sections below address how these variables were tested.

      This study will be performed by a total of six operators at three test sites. At each site,
      two operators will conduct buccal sample collection and analysis. Operators include
      individuals who are technologists, technicians, and/or nurses. The buccal samples will be
      loaded in the Cube within one hour after buccal swab collection. Furthermore, results will be
      generated using multiple platforms (Spartan Cube, computer, and printer) and the same
      platforms will be used at each site. At each site, a total of 64 (8 subjects/operator x 2
      operators x 2 sessions x 2 sub-sessions (replicates)) tests will be run on five
      non-consecutive days. Each day includes 2 sessions and 2 sub-sessions (total 4 collection
      times) in which samples will be collected. Test subject to platform pairing is not required,
      results will be generated on one of the platforms per session. This means that each site will
      generate a total of 320(64 obs./day x 5 days) results over the entire duration of the study.

      To determine lot-to-lot reproducibility of test kits, three different lots will be evaluated.
      For this, two lots will be tested at each site. Each operator will use two lots per session
      on each testing day. Each replicate only includes a single lot of test kits.

      All results generated by the Spartan Cube CYP2C19 System will be compared with the
      bi-directional sequencing results.
allocation: Non-Randomized
intervention model: Single Group Assignment
intervention model description: All subjects receive the same number and type of test for the duration of the study.
primary purpose: Screening
masking: Double (Participant, Investigator)
masking description: Bi-directional sequencing results will not be shard with the participants, operators or Principal investigators.
measure: % Agreement of test results generated on the Spartan Cube CYP2C19 System and bidirectional sequencing
time frame: Through study completion; anticipated to be less than 6 months
description: Determine % agreement across all tests conducted and bi-directional sequencing results
arm group label: Lot to Lot Reproducibility
arm group type: Other
description: The purpose of this arm is to provide evidence to support that each lot of manufactured reagents for the Spartan Cube CYP2C19 Test produce the same result. Each participant, over the course of the study at the various sites, will be tested using 3 different lots of manufactured Spartan CYP2C19 Test Kits.
arm group label: Site to Site Reproducibility
arm group type: Other
description: The purpose of this arm was to provide supporting evidence that showed the same samples (subjects), when tested at different locations, produce the same result.
arm group label: Operator Reproducibility
arm group type: Other
description: The purpose of this arm was to provide supporting evidence that showed the same samples (subjects), when collected and tested by different operators, produce the same result.
intervention type: Device
intervention name: Spartan Cube CYP2C19 System
description: Using buccal material, determine the genotype of the *2, *3 and *17 SNPs of the CYP2C19 gene on the Spartan Cube CYP2C19 System.
arm group label: Lot to Lot Reproducibility
arm group label: Operator Reproducibility
arm group label: Site to Site Reproducibility
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Shaimaa Ahmed, PhD
role: Principal Investigator
affiliation: Spartan Bioscience
facility: 
facility: 
facility: 
country: Canada
responsible party type: Sponsor
sharing ipd: No