<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/NCT02992184</url>
  </required_header>
  <id_info>
    <org_study_id>ANRS HC POC VIRAL DETECTION</org_study_id>
    <nct_id>NCT02992184</nct_id>
  </id_info>
  <brief_title>PoC-HCV Genedrive Viral Detection Assay Validation Study</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>ANRS, Emerging Infectious Diseases</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>EPISTEM</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>ANRS, Emerging Infectious Diseases</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The principal objective is to assess the diagnostic accuracy of the PoC assay (Genedrive,&#xD;
      Epistem) to detect HCV RNA against the reference standard of commercial real-time polymerase&#xD;
      chain reaction (RT-PCR) assay (RealTime HCV, Abbott) using stored heparinized plasma from&#xD;
      patients with chronic hepatitis C and non-infected controls.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2016</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">December 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Accuracy of HCV RNA detection with PoC assay (Genedrive, Epistem) vs reference standard of commercial real-time polymerase chain reaction (RT-PCR) assay (RealTime HCV, Abbott).</measure>
    <time_frame>pre-treatment</time_frame>
    <description>Assess the diagnostic accuracy of the PoC assay (Genedrive, Epistem) to detect HCV RNA against the reference standard of commercial real-time polymerase chain reaction (RT-PCR) assay (RealTime HCV, Abbott) using stored heparinized plasma from patients with chronic hepatitis C and non-infected controls (with Genedrive channel acceptance set at 2 out of 3).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Diagnostic algorithm optimization</measure>
    <time_frame>Pre-treatment</time_frame>
    <description>To optimize the diagnostic algorithm (i.e., 1, 2, or 3 out of 3 channels; repeat testing or not) that gives the optimal balance between sensitivity and specificity for detection of HCV RNA.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Factors associated with false-positive of false-negative results</measure>
    <time_frame>Pre-treatment</time_frame>
    <description>To identify factors associated with false-positive or false-negative results of the PoC assay.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess the inter-examiner reproducibility of the PoC assay.</measure>
    <time_frame>Pre-treatment</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">417</enrollment>
  <condition>Hepatitis C</condition>
  <arm_group>
    <arm_group_label>HCV patients</arm_group_label>
    <description>228 HCV patients</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <description>189 controls</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>HCV RNA detection with Genedrive assay</intervention_name>
    <arm_group_label>HCV patients</arm_group_label>
    <arm_group_label>control</arm_group_label>
    <other_name>HCV RNA detection with Point of Care assay</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>HCV RNA detection with RealTime HCV</intervention_name>
    <arm_group_label>HCV patients</arm_group_label>
    <arm_group_label>control</arm_group_label>
    <other_name>HCV RNA detection with RT-PCR assay</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Pre-treatment cohort: 228 HCV patients samples&#xD;
&#xD;
          -  Age &gt; 18 years old.&#xD;
&#xD;
          -  Patients with positive HCV RNA.&#xD;
&#xD;
          -  Heparinized plasma samples are available before the initiation of antiviral HCV&#xD;
             therapy.&#xD;
&#xD;
          -  Patients have given a written consent that their blood samples will be further used&#xD;
             for research.&#xD;
&#xD;
        Control samples : 189 controls&#xD;
&#xD;
          -  Age &gt; 18 years old.&#xD;
&#xD;
          -  Participants were tested negative for anti-HCV antibody&#xD;
&#xD;
          -  Heparinized plasma samples are available&#xD;
&#xD;
          -  Participants have given a written consent that their blood samples will be further&#xD;
             used for research&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Criteria for case&#xD;
&#xD;
          -  Age &gt; 18 years old.&#xD;
&#xD;
          -  Patients with positive HCV RNA.&#xD;
&#xD;
          -  Heparinized plasma samples are available before the initiation of antiviral HCV&#xD;
             therapy.&#xD;
&#xD;
          -  Patients have given a written consent that their blood samples will be further used&#xD;
             for research.&#xD;
&#xD;
        Criteria for control&#xD;
&#xD;
          -  Age &gt; 18 years old.&#xD;
&#xD;
          -  Participants were tested negative for anti-HCV antibody&#xD;
&#xD;
          -  Heparinized plasma samples are available&#xD;
&#xD;
          -  Participants have given a written consent that their blood samples will be further&#xD;
             used for research&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 12, 2016</study_first_submitted>
  <study_first_submitted_qc>December 13, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 14, 2016</study_first_posted>
  <last_update_submitted>December 13, 2016</last_update_submitted>
  <last_update_submitted_qc>December 13, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 14, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>HCV</keyword>
  <keyword>Genedrive</keyword>
  <keyword>Point of Care</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hepatitis C</mesh_term>
  </condition_browse>
  <!-- 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/NCT02992184
org study id: ANRS HC POC VIRAL DETECTION
nct id: NCT02992184
lead sponsor: 
collaborator: 
has dmc: No
The principal objective is to assess the diagnostic accuracy of the PoC assay (Genedrive,
      Epistem) to detect HCV RNA against the reference standard of commercial real-time polymerase
      chain reaction (RT-PCR) assay (RealTime HCV, Abbott) using stored heparinized plasma from
      patients with chronic hepatitis C and non-infected controls.
observational model: Case-Control
time perspective: Retrospective
measure: Accuracy of HCV RNA detection with PoC assay (Genedrive, Epistem) vs reference standard of commercial real-time polymerase chain reaction (RT-PCR) assay (RealTime HCV, Abbott).
time frame: pre-treatment
description: Assess the diagnostic accuracy of the PoC assay (Genedrive, Epistem) to detect HCV RNA against the reference standard of commercial real-time polymerase chain reaction (RT-PCR) assay (RealTime HCV, Abbott) using stored heparinized plasma from patients with chronic hepatitis C and non-infected controls (with Genedrive channel acceptance set at 2 out of 3).
measure: Diagnostic algorithm optimization
time frame: Pre-treatment
description: To optimize the diagnostic algorithm (i.e., 1, 2, or 3 out of 3 channels; repeat testing or not) that gives the optimal balance between sensitivity and specificity for detection of HCV RNA.
measure: Factors associated with false-positive of false-negative results
time frame: Pre-treatment
description: To identify factors associated with false-positive or false-negative results of the PoC assay.
measure: Assess the inter-examiner reproducibility of the PoC assay.
time frame: Pre-treatment
arm group label: HCV patients
description: 228 HCV patients
arm group label: control
description: 189 controls
intervention type: Device
intervention name: HCV RNA detection with Genedrive assay
arm group label: HCV patients
arm group label: control
other name: HCV RNA detection with Point of Care assay
intervention type: Device
intervention name: HCV RNA detection with RealTime HCV
arm group label: HCV patients
arm group label: control
other name: HCV RNA detection with RT-PCR assay
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor
mesh term: Hepatitis C