<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/NCT01702272</url>
  </required_header>
  <id_info>
    <org_study_id>DENVTS-US12-002</org_study_id>
    <nct_id>NCT01702272</nct_id>
  </id_info>
  <brief_title>Procleix® Dengue Virus Assay Testing of Individual Donor Samples From Puerto Rican and US Blood Donors - CTS</brief_title>
  <official_title>Procleix® Dengue Virus Assay Testing of Individual Donor Samples From Puerto Rican and US Blood Donors - Creative Testing Solutions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gen-Probe, Incorporated</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Gen-Probe, Incorporated</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to test individual donor samples (IDSs) with the&#xD;
      investigational Dengue Assay on the TIGRIS System and to further characterize the Dengue&#xD;
      Assay in the clinical setting.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">January 2014</completion_date>
  <primary_completion_date type="Actual">January 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Qualitative detection of ribosomal RNA from Dengue Virus in plasma specimens from individual human donors, including volunteer donors of whole blood and blood components, and other living donors.</measure>
    <time_frame>Approximately three years</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">150000</enrollment>
  <condition>Dengue</condition>
  <arm_group>
    <arm_group_label>Dengue Virus</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Procleix Dengue Virus Assay</intervention_name>
    <description>in vitro diagnostic assay</description>
    <arm_group_label>Dengue Virus</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        volunteer blood donors from the US and Puerto Rico&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Donor must meet all the blood collection sites' standard eligibility requirements.&#xD;
&#xD;
          -  Donor and/or legally authorized representative must be willing to undergo the site's&#xD;
             routine informed consent process prior to study participation.&#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>Jennifer Reid, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Gen-Probe, Incorporated</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Creative Testing Solutions - Tampa</name>
      <address>
        <city>St Petersburg</city>
        <state>Florida</state>
        <zip>33716</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>October 3, 2012</study_first_submitted>
  <study_first_submitted_qc>October 4, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 8, 2012</study_first_posted>
  <last_update_submitted>September 11, 2014</last_update_submitted>
  <last_update_submitted_qc>September 11, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 15, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dengue</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/NCT01702272
org study id: DENVTS-US12-002
nct id: NCT01702272
lead sponsor: 
has dmc: No
The objective of this study is to test individual donor samples (IDSs) with the
      investigational Dengue Assay on the TIGRIS System and to further characterize the Dengue
      Assay in the clinical setting.
observational model: Cohort
time perspective: Prospective
measure: Qualitative detection of ribosomal RNA from Dengue Virus in plasma specimens from individual human donors, including volunteer donors of whole blood and blood components, and other living donors.
time frame: Approximately three years
arm group label: Dengue Virus
intervention type: Device
intervention name: Procleix Dengue Virus Assay
description: in vitro diagnostic assay
arm group label: Dengue Virus
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jennifer Reid, PhD
role: Study Director
affiliation: Gen-Probe, Incorporated
facility: 
country: United States
responsible party type: Sponsor
mesh term: Dengue