<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/NCT01676298</url>
  </required_header>
  <id_info>
    <org_study_id>01001686</org_study_id>
    <nct_id>NCT01676298</nct_id>
  </id_info>
  <brief_title>Spartan FRX Project Reproducibility Study</brief_title>
  <official_title>Study of the Analytical Reproducibility of the Spartan FRX CYP2C19 *2,*3 and *17 Genotyping System.</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>Ottawa Hospital Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Mount Sinai Hospital, Canada</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Spartan Bioscience Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Spartan FRX CYP2C19 Test System (hereafter referred to as the 'FRX System') is a&#xD;
      qualitative in vitro diagnostic test for the identification of a patient's CYP2C19 *2, *3 and&#xD;
      *17 genotypes from genomic DNA obtained from buccal swab samples. The objective of the study&#xD;
      is to evaluate the performance of the FRX System under multivariate conditions including&#xD;
      different days, sites, operators and systems.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The FRX system is comprised of hardware and consumable components. The hardware components of&#xD;
      the system include an Analyzer (thermal cycler with fluorescence detection capability), a&#xD;
      notebook computer and a printer. The consumable component of the FRX system is a sample&#xD;
      collection kit. Each kit contains a buccal swab (used to collect the patient sample) and a&#xD;
      tube containing the reagents required for genomic DNA extraction and PCR (polymerase chain&#xD;
      reaction) amplification stages of the test.&#xD;
&#xD;
      The Spartan FRX System is capable of detecting three CYP2C19 SNPs(single nucleotide&#xD;
      polymorphism) (*2, *3, *17) in each test performed. An individual sample collection kit is&#xD;
      required for each SNP tested; therefore three sample collection kits are required for each&#xD;
      test performed on the system.&#xD;
&#xD;
      To perform a test, the user collects three buccal samples from the patient and then inserts a&#xD;
      sample into each of the three reagent tubes (one for each of the CYP2C19 loci *2, *3 and&#xD;
      *17). The reagent tubes are placed into the Analyzer and the FRX system automates the&#xD;
      processes of DNA extraction, PCR amplification, fluorescent signal detection and data&#xD;
      analysis. The system provides the user with a printed result listing the patient genotypes at&#xD;
      the *2, *3 and *17 loci.&#xD;
&#xD;
      The objective of the study is to evaluate the performance of the FRX System under&#xD;
      multivariate conditions. Specifically, the following variables will be included in the study:&#xD;
&#xD;
        -  Test site - x3&#xD;
&#xD;
        -  Operator - x6 (2 per site)&#xD;
&#xD;
        -  Day - x15 (5 non-consecutive days per site)&#xD;
&#xD;
        -  FRX System - x16&#xD;
&#xD;
      Test performance is defined as the number of correct genotype calls, expressed as a&#xD;
      percentage of the total number of tests performed on the system.&#xD;
&#xD;
      For both the first-pass and second-pass results, 1-sided 95% confidence lower limits will be&#xD;
      calculated using the score method for the % correct calls (i.e. % agreement).&#xD;
&#xD;
      Genotype results from the FRX system will be compared with results of DNA sequencing. The&#xD;
      result of the FRX System test will be determined to be correct if the genotype calls for all&#xD;
      three SNPs are identical to the genotypes determined by DNA sequencing for that&#xD;
      sample/individual.&#xD;
&#xD;
      Results of the Reproducibility Study will be acceptable if the lower bound of a 1-sided 95%&#xD;
      confidence limit of the total correct call rate per genotype is greater than or equal to 95%,&#xD;
      based on second-pass results.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">November 2012</completion_date>
  <primary_completion_date type="Actual">September 2012</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Correct Calls to Assess Reproducibility of the Spartan FRX CYP2C19 System.</measure>
    <time_frame>After second pass result is complete (~3h)</time_frame>
    <description>Reproducibility was calculated as a percentage of the correct calls over the total calls made for each genotype group. All calls were made using the Spartan FRX CYP2C19 genotyping diagnostic system.&#xD;
All data analyses was qualitative, based on the genotype calls determined by the FRX system (using on-board automated data analysis). A printed result listing the genotype call for each SNP was generated by the FRX system at the end of each run. If the result of a test is &quot;Inconclusive&quot; for one or more SNPs, the test were immediately repeated for the corresponding SNP(s) only, per the instructions for use. Results are reported based on both first-pass and second-pass (i.e. repeated test). For both the first-pass and second-pass results, 1-sided 95% confidence lower limits were calculated using the score method for the % correct calls (i.e. % agreement).</description>
  </primary_outcome>
  <enrollment type="Actual">8</enrollment>
  <condition>Analytical Reproducibility of a Medical Device</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Spartan FRX CYP2C19 Test System</intervention_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        8 Individuals with predetermined CYP2C19 *2,*3 and *17 genotypes&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Above 16 years of age&#xD;
&#xD;
          -  Must have required genotype&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chris JE Harder, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Spartan Bioscience</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Azar Azad, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>MOUNT SINAI HOSPITAL</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Marc Desjardins, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ottawa Hosptial Research Institute</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jean McGowan-Jordan, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Children's Hospital of Eastern Ontario</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>Mount Sinai Services</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 1Z5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>December 2012</verification_date>
  <study_first_submitted>August 28, 2012</study_first_submitted>
  <study_first_submitted_qc>August 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 30, 2012</study_first_posted>
  <results_first_submitted>November 6, 2012</results_first_submitted>
  <results_first_submitted_qc>December 3, 2012</results_first_submitted_qc>
  <results_first_posted type="Estimate">January 7, 2013</results_first_posted>
  <last_update_submitted>December 3, 2012</last_update_submitted>
  <last_update_submitted_qc>December 3, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 7, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cyp2C19</keyword>
  <keyword>Genotyping</keyword>
  <keyword>Spartan</keyword>
  <keyword>Reproducibility</keyword>

  <clinical_results>

    <participant_flow>
      <recruitment_details>A total of 8 individuals were recruited for a company pool of known suspected genotypes; each with a different CYP2C19 genotype confirmed prior to the study by bi-directional sequencing.</recruitment_details>
      <pre_assignment_details>Spartan Bioscience</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>*1/*1 CYP2C19 Genotype</title>
          <description>Subject had genotype confirmed via bi-directional sequencing.</description>
        </group>
        <group group_id="P2">
          <title>*1/*2 CYP2C19 Genotype</title>
          <description>Subject had genotype confirmed via bi-directional sequencing.</description>
        </group>
        <group group_id="P3">
          <title>*2/*2 CYP2C19 Genotype</title>
          <description>Subject had genotype confirmed via bi-directional sequencing.</description>
        </group>
        <group group_id="P4">
          <title>*3/*1 CYP2C19 Genotype</title>
          <description>Subject had genotype confirmed via bi-directional sequencing.</description>
        </group>
        <group group_id="P5">
          <title>*1/*17 CYP2C19 Genotype</title>
          <description>Subject had genotype confirmed via bi-directional sequencing.</description>
        </group>
        <group group_id="P6">
          <title>*17/*17 CYP2C19 Genotype</title>
          <description>Subject had genotype confirmed via bi-directional sequencing.</description>
        </group>
        <group group_id="P7">
          <title>*2/*3 CYP2C19 Genotype</title>
          <description>Subject had genotype confirmed via bi-directional sequencing.</description>
        </group>
        <group group_id="P8">
          <title>*2/*17 CYP2C19 Genotype</title>
          <description>Subject had genotype confirmed via bi-directional sequencing.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="1"/>
                <participants group_id="P8" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>All Genotypes Confirmed With Reference</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="1"/>
                <participants group_id="P8" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Participated in All Tests</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="1"/>
                <participants group_id="P8" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="1"/>
                <participants group_id="P8" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>*1/*1 CYP2C19 Genotype</title>
        </group>
        <group group_id="B2">
          <title>*1/*2 CYP2C19 Genotype</title>
        </group>
        <group group_id="B3">
          <title>*2/*2 CYP2C19 Genotype</title>
        </group>
        <group group_id="B4">
          <title>*3/*1 CYP2C19 Genotype</title>
        </group>
        <group group_id="B5">
          <title>*1/*17 CYP2C19 Genotype</title>
        </group>
        <group group_id="B6">
          <title>*17/*17 CYP2C19 Genotype</title>
        </group>
        <group group_id="B7">
          <title>*2/*3 CYP2C19 Genotype</title>
        </group>
        <group group_id="B8">
          <title>*2/*17 CYP2C19 Genotype</title>
        </group>
        <group group_id="B9">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="1"/>
            <count group_id="B2" value="1"/>
            <count group_id="B3" value="1"/>
            <count group_id="B4" value="1"/>
            <count group_id="B5" value="1"/>
            <count group_id="B6" value="1"/>
            <count group_id="B7" value="1"/>
            <count group_id="B8" value="1"/>
            <count group_id="B9" value="8"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="1"/>
                    <measurement group_id="B9" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="1"/>
                    <measurement group_id="B9" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Canada</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="1"/>
                    <measurement group_id="B9" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Correct Calls to Assess Reproducibility of the Spartan FRX CYP2C19 System.</title>
        <description>Reproducibility was calculated as a percentage of the correct calls over the total calls made for each genotype group. All calls were made using the Spartan FRX CYP2C19 genotyping diagnostic system.&#xD;
All data analyses was qualitative, based on the genotype calls determined by the FRX system (using on-board automated data analysis). A printed result listing the genotype call for each SNP was generated by the FRX system at the end of each run. If the result of a test is &quot;Inconclusive&quot; for one or more SNPs, the test were immediately repeated for the corresponding SNP(s) only, per the instructions for use. Results are reported based on both first-pass and second-pass (i.e. repeated test). For both the first-pass and second-pass results, 1-sided 95% confidence lower limits were calculated using the score method for the % correct calls (i.e. % agreement).</description>
        <time_frame>After second pass result is complete (~3h)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>*1/*1 CYP2C19 Genotype</title>
            <description>Subject had genotype confirmed via bi-directional sequencing.</description>
          </group>
          <group group_id="O2">
            <title>*1/*2 CYP2C19 Genotype</title>
            <description>Subject had genotype confirmed via bi-directional sequencing.</description>
          </group>
          <group group_id="O3">
            <title>*2/*2 CYP2C19 Genotype</title>
            <description>Subject had genotype confirmed via bi-directional sequencing.</description>
          </group>
          <group group_id="O4">
            <title>*3/*1 CYP2C19 Genotype</title>
            <description>Subject had genotype confirmed via bi-directional sequencing.</description>
          </group>
          <group group_id="O5">
            <title>*1/*17 CYP2C19 Genotype</title>
            <description>Subject had genotype confirmed via bi-directional sequencing.</description>
          </group>
          <group group_id="O6">
            <title>*17/*17 CYP2C19 Genotype</title>
            <description>Subject had genotype confirmed via bi-directional sequencing.</description>
          </group>
          <group group_id="O7">
            <title>*2/*3 CYP2C19 Genotype</title>
            <description>Subject had genotype confirmed via bi-directional sequencing.</description>
          </group>
          <group group_id="O8">
            <title>*2/*17 CYP2C19 Genotype</title>
            <description>Subject had genotype confirmed via bi-directional sequencing.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Correct Calls to Assess Reproducibility of the Spartan FRX CYP2C19 System.</title>
          <description>Reproducibility was calculated as a percentage of the correct calls over the total calls made for each genotype group. All calls were made using the Spartan FRX CYP2C19 genotyping diagnostic system.&#xD;
All data analyses was qualitative, based on the genotype calls determined by the FRX system (using on-board automated data analysis). A printed result listing the genotype call for each SNP was generated by the FRX system at the end of each run. If the result of a test is &quot;Inconclusive&quot; for one or more SNPs, the test were immediately repeated for the corresponding SNP(s) only, per the instructions for use. Results are reported based on both first-pass and second-pass (i.e. repeated test). For both the first-pass and second-pass results, 1-sided 95% confidence lower limits were calculated using the score method for the % correct calls (i.e. % agreement).</description>
          <units>Percentage of Correct Calls</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <units_analyzed>Participants</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="1"/>
                <count group_id="O3" value="1"/>
                <count group_id="O4" value="1"/>
                <count group_id="O5" value="1"/>
                <count group_id="O6" value="1"/>
                <count group_id="O7" value="1"/>
                <count group_id="O8" value="1"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>CYP2C19 Genotype</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="120"/>
                <count group_id="O2" value="120"/>
                <count group_id="O3" value="200"/>
                <count group_id="O4" value="120"/>
                <count group_id="O5" value="120"/>
                <count group_id="O6" value="120"/>
                <count group_id="O7" value="120"/>
                <count group_id="O8" value="120"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.3" lower_limit="95.1" upper_limit="99.4"/>
                    <measurement group_id="O2" value="100" lower_limit="97.8" upper_limit="100"/>
                    <measurement group_id="O3" value="97.5" lower_limit="95" upper_limit="98.8"/>
                    <measurement group_id="O4" value="99.2" lower_limit="96.4" upper_limit="99.8"/>
                    <measurement group_id="O5" value="100" lower_limit="97.8" upper_limit="100"/>
                    <measurement group_id="O6" value="99.2" lower_limit="96.4" upper_limit="99.8"/>
                    <measurement group_id="O7" value="99.2" lower_limit="96.4" upper_limit="99.8"/>
                    <measurement group_id="O8" value="99.2" lower_limit="96.4" upper_limit="99.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were monitored for the full duration of the trial (~2 months).</time_frame>
      <desc>No adverse events were encountered.</desc>
      <group_list>
        <group group_id="E1">
          <title>*1/*1 CYP2C19 Genotype</title>
        </group>
        <group group_id="E2">
          <title>*1/*2 CYP2C19 Genotype</title>
        </group>
        <group group_id="E3">
          <title>*2/*2 CYP2C19 Genotype</title>
        </group>
        <group group_id="E4">
          <title>*3/*1 CYP2C19 Genotype</title>
        </group>
        <group group_id="E5">
          <title>*1/*17 CYP2C19 Genotype</title>
        </group>
        <group group_id="E6">
          <title>*17/*17 CYP2C19 Genotype</title>
        </group>
        <group group_id="E7">
          <title>*2/*3 CYP2C19 Genotype</title>
        </group>
        <group group_id="E8">
          <title>*2/*17 CYP2C19 Genotype</title>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Chris Harder</name_or_title>
      <organization>Spartan Bioscience Inc.</organization>
      <phone>613-228-7756 ext 778</phone>
      <email>chris.harder@spartanbio.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01676298
org study id: 01001686
nct id: NCT01676298
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The Spartan FRX CYP2C19 Test System (hereafter referred to as the 'FRX System') is a
      qualitative in vitro diagnostic test for the identification of a patient's CYP2C19 *2, *3 and
      *17 genotypes from genomic DNA obtained from buccal swab samples. The objective of the study
      is to evaluate the performance of the FRX System under multivariate conditions including
      different days, sites, operators and systems.
The FRX system is comprised of hardware and consumable components. The hardware components of
      the system include an Analyzer (thermal cycler with fluorescence detection capability), a
      notebook computer and a printer. The consumable component of the FRX system is a sample
      collection kit. Each kit contains a buccal swab (used to collect the patient sample) and a
      tube containing the reagents required for genomic DNA extraction and PCR (polymerase chain
      reaction) amplification stages of the test.

      The Spartan FRX System is capable of detecting three CYP2C19 SNPs(single nucleotide
      polymorphism) (*2, *3, *17) in each test performed. An individual sample collection kit is
      required for each SNP tested; therefore three sample collection kits are required for each
      test performed on the system.

      To perform a test, the user collects three buccal samples from the patient and then inserts a
      sample into each of the three reagent tubes (one for each of the CYP2C19 loci *2, *3 and
      *17). The reagent tubes are placed into the Analyzer and the FRX system automates the
      processes of DNA extraction, PCR amplification, fluorescent signal detection and data
      analysis. The system provides the user with a printed result listing the patient genotypes at
      the *2, *3 and *17 loci.

      The objective of the study is to evaluate the performance of the FRX System under
      multivariate conditions. Specifically, the following variables will be included in the study:

        -  Test site - x3

        -  Operator - x6 (2 per site)

        -  Day - x15 (5 non-consecutive days per site)

        -  FRX System - x16

      Test performance is defined as the number of correct genotype calls, expressed as a
      percentage of the total number of tests performed on the system.

      For both the first-pass and second-pass results, 1-sided 95% confidence lower limits will be
      calculated using the score method for the % correct calls (i.e. % agreement).

      Genotype results from the FRX system will be compared with results of DNA sequencing. The
      result of the FRX System test will be determined to be correct if the genotype calls for all
      three SNPs are identical to the genotypes determined by DNA sequencing for that
      sample/individual.

      Results of the Reproducibility Study will be acceptable if the lower bound of a 1-sided 95%
      confidence limit of the total correct call rate per genotype is greater than or equal to 95%,
      based on second-pass results.
time perspective: Prospective
measure: Percentage of Correct Calls to Assess Reproducibility of the Spartan FRX CYP2C19 System.
time frame: After second pass result is complete (~3h)
description: Reproducibility was calculated as a percentage of the correct calls over the total calls made for each genotype group. All calls were made using the Spartan FRX CYP2C19 genotyping diagnostic system.
All data analyses was qualitative, based on the genotype calls determined by the FRX system (using on-board automated data analysis). A printed result listing the genotype call for each SNP was generated by the FRX system at the end of each run. If the result of a test is "Inconclusive" for one or more SNPs, the test were immediately repeated for the corresponding SNP(s) only, per the instructions for use. Results are reported based on both first-pass and second-pass (i.e. repeated test). For both the first-pass and second-pass results, 1-sided 95% confidence lower limits were calculated using the score method for the % correct calls (i.e. % agreement).
intervention type: Device
intervention name: Spartan FRX CYP2C19 Test System
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Chris JE Harder, PhD
role: Principal Investigator
affiliation: Spartan Bioscience
last name: Azar Azad, PhD
role: Principal Investigator
affiliation: MOUNT SINAI HOSPITAL
last name: Marc Desjardins, PhD
role: Principal Investigator
affiliation: Ottawa Hosptial Research Institute
last name: Jean McGowan-Jordan, PhD
role: Principal Investigator
affiliation: Children's Hospital of Eastern Ontario
facility: 
facility: 
facility: 
country: Canada
responsible party type: Sponsor
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 