<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/NCT04473586</url>
  </required_header>
  <id_info>
    <org_study_id>VNV-00229</org_study_id>
    <nct_id>NCT04473586</nct_id>
  </id_info>
  <brief_title>Spartan Cube CYP2C19 Method Comparison Study</brief_title>
  <official_title>Validation Protocol Spartan Cube CYP2C19- Method Comparison</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Spartan Bioscience Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Mount Sinai Services</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study is to demonstrate concordance (percent agreement) between results&#xD;
      produced by the Spartan CYP2C19 system and bi-directional sequencing. In addition, this study&#xD;
      will evaluate the concordance of buccal samples stored prior to running on the Spartan Cube&#xD;
      CYP2C19 system and bi-directional sequencing.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Sample holding time - two parts&#xD;
&#xD;
        1. Sample tested in less than one-hour&#xD;
&#xD;
           a.In the first part, buccal samples will be collected from subjects and tested using the&#xD;
           Spartan Cube CYP2C19 system. These samples will be run immediately (within 1 h) after&#xD;
           collection from the subject (&lt;1 h sample holding time). All results will be compared to&#xD;
           bi-directional sequencing to determine percent agreement.&#xD;
&#xD;
        2. Sample tested greater than 21 hours a.In the second part (sample holding portion),&#xD;
           samples will be tested using the Spartan Cube CYP2C19 product. These samples will be run&#xD;
           after storage at ambient temperature. All results will be compared to bi-directional&#xD;
           sequencing to determine the percent agreement.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 5, 2020</start_date>
  <completion_date type="Actual">March 6, 2020</completion_date>
  <primary_completion_date type="Actual">March 6, 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 will experienced the same number of buccal and saliva samples collected. This means all subjects will participate in Arm 1 and have materials collected at the same time in the event they are enrolled in arm 2.&#xD;
Based on enrollment numbers and their immediate genotype, it will be determined at that time if the subject will participate in the second arm of the study.</intervention_model_description>
    <primary_purpose>Screening</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>Bi-directional sequencing results and Spartan results will not be shared with participants. The investigator will not see the bi-directional sequencing results.</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 4 months</time_frame>
    <description>Determine % agreement across all tests conducted and bi-directional sequencing results</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">425</enrollment>
  <condition>Genotyping Techniques</condition>
  <arm_group>
    <arm_group_label>Sample tested in less than one-hour</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Buccal samples will be collected and analyzed on the Spartan Cube CYP2C19 System immediately (&lt;1hr). The Spartan Cube CYP2C19 results will be compared with bi-directional sequencing results generated by a third part from a saliva sample collected from the same subject.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Samples tested greater than 24 hours</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Buccal samples will be collected, stored and then analyzed on the Spartan Cube CYP2C19 System greater than 24 hours after collection. The Spartan Cube CYP2C19 results will be compared with bi-directional sequencing results generated by a third part from a saliva sample collected from the same subject.</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>Sample tested in less than one-hour</arm_group_label>
    <arm_group_label>Samples tested greater than 24 hours</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants who will provide buccal samples and a saliva sample who have not eaten&#xD;
             drank or smoked in the past 30 minutes.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants who have eaten drank or smoked in the past 30 minutes prior to&#xD;
             collection.&#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 Inc.</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>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>Method Comparison</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/NCT04473586
org study id: VNV-00229
nct id: NCT04473586
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of the study is to demonstrate concordance (percent agreement) between results
      produced by the Spartan CYP2C19 system and bi-directional sequencing. In addition, this study
      will evaluate the concordance of buccal samples stored prior to running on the Spartan Cube
      CYP2C19 system and bi-directional sequencing.
Sample holding time - two parts

        1. Sample tested in less than one-hour

           a.In the first part, buccal samples will be collected from subjects and tested using the
           Spartan Cube CYP2C19 system. These samples will be run immediately (within 1 h) after
           collection from the subject (<1 h sample holding time). All results will be compared to
           bi-directional sequencing to determine percent agreement.

        2. Sample tested greater than 21 hours a.In the second part (sample holding portion),
           samples will be tested using the Spartan Cube CYP2C19 product. These samples will be run
           after storage at ambient temperature. All results will be compared to bi-directional
           sequencing to determine the percent agreement.
allocation: Non-Randomized
intervention model: Single Group Assignment
intervention model description: All subjects will experienced the same number of buccal and saliva samples collected. This means all subjects will participate in Arm 1 and have materials collected at the same time in the event they are enrolled in arm 2.
Based on enrollment numbers and their immediate genotype, it will be determined at that time if the subject will participate in the second arm of the study.
primary purpose: Screening
masking: Double (Participant, Investigator)
masking description: Bi-directional sequencing results and Spartan results will not be shared with participants. The investigator will not see the bi-directional sequencing results.
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 4 months
description: Determine % agreement across all tests conducted and bi-directional sequencing results
arm group label: Sample tested in less than one-hour
arm group type: Other
description: Buccal samples will be collected and analyzed on the Spartan Cube CYP2C19 System immediately (<1hr). The Spartan Cube CYP2C19 results will be compared with bi-directional sequencing results generated by a third part from a saliva sample collected from the same subject.
arm group label: Samples tested greater than 24 hours
arm group type: Other
description: Buccal samples will be collected, stored and then analyzed on the Spartan Cube CYP2C19 System greater than 24 hours after collection. The Spartan Cube CYP2C19 results will be compared with bi-directional sequencing results generated by a third part from a saliva sample collected from the same subject.
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: Sample tested in less than one-hour
arm group label: Samples tested greater than 24 hours
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 Inc.
facility: 
country: Canada
responsible party type: Sponsor
sharing ipd: No