<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/NCT01694875</url>
  </required_header>
  <id_info>
    <org_study_id>HPVGPS-US12-001</org_study_id>
    <nct_id>NCT01694875</nct_id>
  </id_info>
  <brief_title>Clinical Evaluation of the APTIMA® HPV 16 18/45 Genotype Assay on the PANTHER® System</brief_title>
  <official_title>Clinical Evaluation of the APTIMA® HPV 16 18/45 Genotype Assay on the PANTHER® System in Women With ASC-US Pap Test Results and in Women 30 Years of Age or Older With Negative Pap Test Results Using ThinPrep Pap Test Specimens</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 the clinical study is to evaluate the AHPV-GT Assay using the PANTHER System&#xD;
      in cervical cancer screening.&#xD;
&#xD;
      This objective will be accomplished in the ASC-US Study by evaluating the performance&#xD;
      characteristics of the AHPV-GT Assay using the PANTHER System in a sample population of women&#xD;
      with ASC-US Pap test results who were 21 years of age or older (&quot;≥21 years of age&quot;) at the&#xD;
      time of their Pap visit. For the Adjunct Study, this objective will be accomplished by&#xD;
      evaluating the ability of the AHPV-GT Assay using the PANTHER System to identify women at&#xD;
      increased risk of cervical disease in a sample population of women with negative&#xD;
      (NILM)cytology results who were ≥30 years of age at the time of their Pap visit.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">November 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>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">2200</enrollment>
  <condition>Human Papillomavirus Infection</condition>
  <arm_group>
    <arm_group_label>No Treatment</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>APTIMA HPV Assay</intervention_name>
    <description>In Vitro Diagnostics Assay</description>
    <arm_group_label>No Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Samples from subjects who attended colposcopy from the Adjunct Study and subjects who had&#xD;
        positive APTIMA HPV Assay results in the APTIMA HPV Assay TIGRIS System Study or the APTIMA&#xD;
        HPV Assay PANTHER System Study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Subjects who were previously enrolled into the prospective, multicenter US clinical study&#xD;
        for the APTIMA HPV Assay on the TIGRIS System (protocol 2007HPVASCUS30) will be eligible&#xD;
        for inclusion in the study of the AHPV-GT Assay using the PANTHER System described in this&#xD;
        protocol. All evaluable ASC-US Study subjects ≥21 years of age will be eligible for&#xD;
        inclusion.&#xD;
&#xD;
        Evaluable Adjunct Study subjects ≥30 years of age will be eligible if the following&#xD;
        criteria are met:&#xD;
&#xD;
          -  the subject attended the colposcopy visit, or&#xD;
&#xD;
          -  the subject did not attend the colposcopy visit but the referral Pap sample had a&#xD;
             positive APTIMA HPV Assay result in the APTIMA HPV Assay TIGRIS System study (protocol&#xD;
             2007HPVASCUS30) or in the APTIMA HPV Assay PANTHER System study (protocol&#xD;
             AHPVPS-US11-003).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Eligible subjects will be excluded if they do not have an evaluable sample. This may be due&#xD;
        to insufficient volume or because the sample was deemed unsuitable for testing (eg, stored&#xD;
        under unacceptable conditions).&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jennifer L Reid, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Gen-Probe, Incorporated</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hennepin County Medical Center</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55415</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Laboratory Corporation of America</name>
      <address>
        <city>Burlington</city>
        <state>North Carolina</state>
        <zip>27215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Molecular Pathology Laboratory Network, Inc</name>
      <address>
        <city>Maryville</city>
        <state>Tennessee</state>
        <zip>37804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>September 24, 2012</study_first_submitted>
  <study_first_submitted_qc>September 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 27, 2012</study_first_posted>
  <last_update_submitted>November 12, 2012</last_update_submitted>
  <last_update_submitted_qc>November 12, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 14, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>cervix cancer</keyword>
  <keyword>HPV</keyword>
  <keyword>APTIMA</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Papillomavirus Infections</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/NCT01694875
org study id: HPVGPS-US12-001
nct id: NCT01694875
lead sponsor: 
has dmc: No
The objective of the clinical study is to evaluate the AHPV-GT Assay using the PANTHER System
      in cervical cancer screening.

      This objective will be accomplished in the ASC-US Study by evaluating the performance
      characteristics of the AHPV-GT Assay using the PANTHER System in a sample population of women
      with ASC-US Pap test results who were 21 years of age or older ("≥21 years of age") at the
      time of their Pap visit. For the Adjunct Study, this objective will be accomplished by
      evaluating the ability of the AHPV-GT Assay using the PANTHER System to identify women at
      increased risk of cervical disease in a sample population of women with negative
      (NILM)cytology results who were ≥30 years of age at the time of their Pap visit.
observational model: Cohort
time perspective: Retrospective
arm group label: No Treatment
intervention type: Device
intervention name: APTIMA HPV Assay
description: In Vitro Diagnostics Assay
arm group label: No Treatment
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 21 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jennifer L Reid, PhD
role: Study Director
affiliation: Gen-Probe, Incorporated
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Papillomavirus Infections