<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/NCT01718535</url>
  </required_header>
  <id_info>
    <org_study_id>01001679</org_study_id>
    <nct_id>NCT01718535</nct_id>
  </id_info>
  <brief_title>Method Comparison Study of the Spartan FRX CYP2C19 Genotyping System Against Bi-directional Sequencing</brief_title>
  <official_title>Method Comparison Study 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>Mount Sinai Hospital, Canada</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Spartan Bioscience Inc.</source>
  <oversight_info>
    <has_dmc>Yes</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. This study is purposed to&#xD;
      demonstrate the concordance (positive and negative percent agreement) by comparing the&#xD;
      Spartan FRX system against bi-directional DNA sequencing. The study will also evaluate the&#xD;
      concordance between three different sample transport embodiments provided to laboratories for&#xD;
      use in transporting the reagent tubes with collected buccal sample swab to the laboratory.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <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.&#xD;
&#xD;
      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;
      netbook 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 amplification stages&#xD;
      of the test.&#xD;
&#xD;
      The Spartan FRX System is capable of detecting three CYP2C19 SNPs (*2, *3, *17) in each test&#xD;
      performed. An individual sample collection kit is required for each SNP tested; therefore&#xD;
      three sample collection kits are required for each test performed on the system.&#xD;
&#xD;
      The FRX System is to be used by trained personnel in CLIA certified laboratories and is for&#xD;
      use with buccal samples collected directly from patients. The FRX CYP2C19 test is intended to&#xD;
      enable clinicians to identify patients with mutations in the *2,*3 and *17 loci of the&#xD;
      CYP2C19 gene and is indicated for use as an aid to clinicians in determining strategies for&#xD;
      therapeutics that are metabolized by the CYP2C19 gene product.&#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;
      This study has been designed to demonstrate the concordance (positive and negative percent&#xD;
      agreement) by comparing the Spartan FRX system against bi-directional DNA sequencing. The&#xD;
      study will also evaluate the concordance between three different sample transport embodiments&#xD;
      provided to laboratories for use in transporting the reagent tubes with collected buccal&#xD;
      sample swab to the laboratory.&#xD;
&#xD;
      For each mutation, agreement of the FRX System against bidirectional sequencing (comparative&#xD;
      method) will be calculated: The overall accuracy of the test will be calculated and reported&#xD;
      as follows:&#xD;
&#xD;
        -  of concordant results between the test and the reference method Accuracy =&#xD;
           ----------------------------------------------------------------&#xD;
&#xD;
        -  of samples analyzed by the reference method&#xD;
&#xD;
      The first and second pass results from the study will be analyzed and tabulated as outlined&#xD;
      in the table below. The acceptance criteria for the overall study will be percent in&#xD;
      agreement ≥ 99.0% for the second pass with the lower bound of a one-sided 95% confidence&#xD;
      interval using the score method ≥ 95.0%.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">December 2012</completion_date>
  <primary_completion_date type="Actual">November 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>Percent Agreement</measure>
    <time_frame>After second pass result is complete (~3hours)</time_frame>
    <description>The study will pass if the percent agreement is ≥ 99.0% and the lower bound of a 1-sided 95% confidence interval is ≥ 95.0% using the score method.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">327</enrollment>
  <condition>Genotyping Techniques</condition>
  <arm_group>
    <arm_group_label>CYP2C19 Genotyping</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Spartan FRX CYP2C19 Test System</intervention_name>
    <arm_group_label>CYP2C19 Genotyping</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        320 Individuals with undetermined CYP2C19 *2 *3 and *17 Genotypes&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        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>Azar Azad, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mount Sinai Hospital, Canada</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mount Sinai Services</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G1Z5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>May 2013</verification_date>
  <study_first_submitted>October 29, 2012</study_first_submitted>
  <study_first_submitted_qc>October 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 31, 2012</study_first_posted>
  <results_first_submitted>February 7, 2013</results_first_submitted>
  <results_first_submitted_qc>May 28, 2013</results_first_submitted_qc>
  <results_first_posted type="Estimate">August 28, 2013</results_first_posted>
  <last_update_submitted>May 28, 2013</last_update_submitted>
  <last_update_submitted_qc>May 28, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 28, 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>Comparison</keyword>
  <keyword>Sequencing</keyword>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Recruitment of study participants was performed without knowledge of participant genotypes by enrolling associates of operators and associates of Spartan Bioscience and Mount Sinai Services.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>*1/*1 CYP2C19 Genotype</title>
        </group>
        <group group_id="P2">
          <title>*1/*2 CYP2C19 Genotype</title>
        </group>
        <group group_id="P3">
          <title>*2/*2 CYP2C19 Genotype</title>
        </group>
        <group group_id="P4">
          <title>*1/*3 CYP2C19 Genotype</title>
        </group>
        <group group_id="P5">
          <title>*3/*3 CYP2C19 Genotype</title>
        </group>
        <group group_id="P6">
          <title>*1/*17 CYP2C19 Genotype</title>
        </group>
        <group group_id="P7">
          <title>*17/*17 CYP2C19 Genotype</title>
        </group>
        <group group_id="P8">
          <title>*2/*3 CYP2C19 Genotype</title>
        </group>
        <group group_id="P9">
          <title>*2/*17 CYP2C19 Genotype</title>
        </group>
        <group group_id="P10">
          <title>*3/*17 CYP2C19 Genotype</title>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="131"/>
                <participants group_id="P2" count="95"/>
                <participants group_id="P3" count="19"/>
                <participants group_id="P4" count="8"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="40"/>
                <participants group_id="P7" count="11"/>
                <participants group_id="P8" count="6"/>
                <participants group_id="P9" count="15"/>
                <participants group_id="P10" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>First Pass</title>
              <participants_list>
                <participants group_id="P1" count="128"/>
                <participants group_id="P2" count="94"/>
                <participants group_id="P3" count="19"/>
                <participants group_id="P4" count="7"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="39"/>
                <participants group_id="P7" count="11"/>
                <participants group_id="P8" count="6"/>
                <participants group_id="P9" count="15"/>
                <participants group_id="P10" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="130"/>
                <participants group_id="P2" count="95"/>
                <participants group_id="P3" count="19"/>
                <participants group_id="P4" count="7"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="40"/>
                <participants group_id="P7" count="11"/>
                <participants group_id="P8" count="6"/>
                <participants group_id="P9" count="15"/>
                <participants group_id="P10" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <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 group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Bidirectional Sequencing not possible</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <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 group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_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>*1/*3 CYP2C19 Genotype</title>
        </group>
        <group group_id="B5">
          <title>*3/*3 CYP2C19 Genotype</title>
        </group>
        <group group_id="B6">
          <title>*1/*17 CYP2C19 Genotype</title>
        </group>
        <group group_id="B7">
          <title>*17/*17 CYP2C19 Genotype</title>
        </group>
        <group group_id="B8">
          <title>*2/*3 CYP2C19 Genotype</title>
        </group>
        <group group_id="B9">
          <title>*2/*17 CYP2C19 Genotype</title>
        </group>
        <group group_id="B10">
          <title>*3/*17 CYP2C19 Genotype</title>
        </group>
        <group group_id="B11">
          <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="130"/>
            <count group_id="B2" value="95"/>
            <count group_id="B3" value="19"/>
            <count group_id="B4" value="7"/>
            <count group_id="B5" value="1"/>
            <count group_id="B6" value="40"/>
            <count group_id="B7" value="11"/>
            <count group_id="B8" value="6"/>
            <count group_id="B9" value="15"/>
            <count group_id="B10" value="1"/>
            <count group_id="B11" value="325"/>
          </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="3"/>
                    <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="1"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="124"/>
                    <measurement group_id="B2" value="95"/>
                    <measurement group_id="B3" value="19"/>
                    <measurement group_id="B4" value="7"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="38"/>
                    <measurement group_id="B7" value="9"/>
                    <measurement group_id="B8" value="6"/>
                    <measurement group_id="B9" value="15"/>
                    <measurement group_id="B10" value="1"/>
                    <measurement group_id="B11" value="315"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <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="1"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex/Gender, Customized</title>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Gender Not Collected</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="130"/>
                    <measurement group_id="B2" value="95"/>
                    <measurement group_id="B3" value="19"/>
                    <measurement group_id="B4" value="7"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="40"/>
                    <measurement group_id="B7" value="11"/>
                    <measurement group_id="B8" value="6"/>
                    <measurement group_id="B9" value="15"/>
                    <measurement group_id="B10" value="1"/>
                    <measurement group_id="B11" value="325"/>
                  </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="130"/>
                    <measurement group_id="B2" value="95"/>
                    <measurement group_id="B3" value="19"/>
                    <measurement group_id="B4" value="7"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="40"/>
                    <measurement group_id="B7" value="11"/>
                    <measurement group_id="B8" value="6"/>
                    <measurement group_id="B9" value="15"/>
                    <measurement group_id="B10" value="1"/>
                    <measurement group_id="B11" value="325"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percent Agreement</title>
        <description>The study will pass if the percent agreement is ≥ 99.0% and the lower bound of a 1-sided 95% confidence interval is ≥ 95.0% using the score method.</description>
        <time_frame>After second pass result is complete (~3hours)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>*1/*1 CYP2C19 Genotype</title>
          </group>
          <group group_id="O2">
            <title>*1/*2 CYP2C19 Genotype</title>
          </group>
          <group group_id="O3">
            <title>*2/*2 CYP2C19 Genotype</title>
          </group>
          <group group_id="O4">
            <title>*1/*3 CYP2C19 Genotype</title>
          </group>
          <group group_id="O5">
            <title>*3/*3 CYP2C19 Genotype</title>
          </group>
          <group group_id="O6">
            <title>*1/*17 CYP2C19 Genotype</title>
          </group>
          <group group_id="O7">
            <title>*17/*17 CYP2C19 Genotype</title>
          </group>
          <group group_id="O8">
            <title>*2/*3 CYP2C19 Genotype</title>
          </group>
          <group group_id="O9">
            <title>*2/*17 CYP2C19 Genotype</title>
          </group>
          <group group_id="O10">
            <title>*3/*17 CYP2C19 Genotype</title>
          </group>
        </group_list>
        <measure>
          <title>Percent Agreement</title>
          <description>The study will pass if the percent agreement is ≥ 99.0% and the lower bound of a 1-sided 95% confidence interval is ≥ 95.0% using the score method.</description>
          <units>Percent Agreement</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="130"/>
                <count group_id="O2" value="95"/>
                <count group_id="O3" value="19"/>
                <count group_id="O4" value="7"/>
                <count group_id="O5" value="1"/>
                <count group_id="O6" value="40"/>
                <count group_id="O7" value="11"/>
                <count group_id="O8" value="6"/>
                <count group_id="O9" value="15"/>
                <count group_id="O10" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100" lower_limit="98" upper_limit="100"/>
                    <measurement group_id="O2" value="100" lower_limit="97" upper_limit="100"/>
                    <measurement group_id="O3" value="100" lower_limit="88" upper_limit="100"/>
                    <measurement group_id="O4" value="100" lower_limit="72" upper_limit="100"/>
                    <measurement group_id="O5" value="100" lower_limit="27" upper_limit="100"/>
                    <measurement group_id="O6" value="100" lower_limit="94" upper_limit="100"/>
                    <measurement group_id="O7" value="100" lower_limit="80" upper_limit="100"/>
                    <measurement group_id="O8" value="100" lower_limit="69" upper_limit="100"/>
                    <measurement group_id="O9" value="100" lower_limit="85" upper_limit="100"/>
                    <measurement group_id="O10" value="100" lower_limit="27" upper_limit="100"/>
                  </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 (~1 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>*1/*3 CYP2C19 Genotype</title>
        </group>
        <group group_id="E5">
          <title>*3/*3 CYP2C19 Genotype</title>
        </group>
        <group group_id="E6">
          <title>*1/*17 CYP2C19 Genotype</title>
        </group>
        <group group_id="E7">
          <title>*17/*17 CYP2C19 Genotype</title>
        </group>
        <group group_id="E8">
          <title>*2/*3 CYP2C19 Genotype</title>
        </group>
        <group group_id="E9">
          <title>*2/*17 CYP2C19 Genotype</title>
        </group>
        <group group_id="E10">
          <title>*3/*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="131"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="1"/>
              </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="131"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="1"/>
              </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>Azar Azad</name_or_title>
      <organization>Mount Sinai Services Inc.</organization>
      <phone>416-856-8545</phone>
      <email>aazad@mtsinai.on.ca</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/NCT01718535
org study id: 01001679
nct id: NCT01718535
lead sponsor: 
collaborator: 
has dmc: Yes
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. This study is purposed to
      demonstrate the concordance (positive and negative percent agreement) by comparing the
      Spartan FRX system against bi-directional DNA sequencing. The study will also evaluate the
      concordance between three different sample transport embodiments provided to laboratories for
      use in transporting the reagent tubes with collected buccal sample swab to the laboratory.
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 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
      netbook 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 amplification stages
      of the test.

      The Spartan FRX System is capable of detecting three CYP2C19 SNPs (*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.

      The FRX System is to be used by trained personnel in CLIA certified laboratories and is for
      use with buccal samples collected directly from patients. The FRX CYP2C19 test is intended to
      enable clinicians to identify patients with mutations in the *2,*3 and *17 loci of the
      CYP2C19 gene and is indicated for use as an aid to clinicians in determining strategies for
      therapeutics that are metabolized by the CYP2C19 gene product.

      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.

      This study has been designed to demonstrate the concordance (positive and negative percent
      agreement) by comparing the Spartan FRX system against bi-directional DNA sequencing. The
      study will also evaluate the concordance between three different sample transport embodiments
      provided to laboratories for use in transporting the reagent tubes with collected buccal
      sample swab to the laboratory.

      For each mutation, agreement of the FRX System against bidirectional sequencing (comparative
      method) will be calculated: The overall accuracy of the test will be calculated and reported
      as follows:

        -  of concordant results between the test and the reference method Accuracy =
           ----------------------------------------------------------------

        -  of samples analyzed by the reference method

      The first and second pass results from the study will be analyzed and tabulated as outlined
      in the table below. The acceptance criteria for the overall study will be percent in
      agreement ≥ 99.0% for the second pass with the lower bound of a one-sided 95% confidence
      interval using the score method ≥ 95.0%.
time perspective: Prospective
measure: Percent Agreement
time frame: After second pass result is complete (~3hours)
description: The study will pass if the percent agreement is ≥ 99.0% and the lower bound of a 1-sided 95% confidence interval is ≥ 95.0% using the score method.
arm group label: CYP2C19 Genotyping
intervention type: Device
intervention name: Spartan FRX CYP2C19 Test System
arm group label: CYP2C19 Genotyping
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: Azar Azad, PhD
role: Principal Investigator
affiliation: Mount Sinai Hospital, Canada
facility: 
country: Canada
responsible party type: Sponsor
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 