<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/NCT01671462</url>
  </required_header>
  <id_info>
    <org_study_id>MDX-11-EUHPV</org_study_id>
    <nct_id>NCT01671462</nct_id>
  </id_info>
  <brief_title>European Clinical Evaluation of the BD HPV Assay on the BD Viper LT System</brief_title>
  <official_title>European Clinical Evaluation of the BD HPV Assay on the BD Viper LT System</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Becton, Dickinson and Company</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Becton, Dickinson and Company</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to compare the results of the Becton Dickinson (BD) Human&#xD;
      Papilloma Virus (HPV) Assay on the Viper LT instrument from SurePath media diluted in HPV&#xD;
      diluent (pre-quot and/or residual), PreservCyt media diluted in HPV diluent (pre-quot and/or&#xD;
      residual) and a BD cervical brush in BD transport medium to reference histology results from&#xD;
      biopsy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a multicenter study consisting of 2-3 European clinical trial sites, and up to 2 BD&#xD;
      Viper LT Systems.&#xD;
&#xD;
      The BD HPV Diluent tube will be run on the BD HPV assay with the Viper LT instrument and&#xD;
      compared to histology, Digene hybrid capture 2 (HC2), and Roche LINEAR ARRAY HPV Genotyping&#xD;
      Test results.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">November 2013</completion_date>
  <primary_completion_date type="Actual">November 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <primary_outcome>
    <measure>Sensitivity of the BD HPV Assay with 95% confidence intervals for detecting cervical disease as defined by Cervical Intraepithelial Neoplasia (CIN2) or higher.</measure>
    <time_frame>Nine months</time_frame>
    <description>Sensitivity is calculated: Number of subjects with positive BD HPV test and with histology results of CIN2 or greater divided by the total number of subjects with histology results of CIN2 or greater</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Specificity of the BD HPV Assay with 95% confidence intervals for detecting cervical disease as defined by Cervical Intraepithelial Neoplasia (CIN2) or higher.</measure>
    <time_frame>Nine months</time_frame>
    <description>Specificity is calculated: Number of subjects with a negative BD HPV test and with histology results of less than CIN2 divided by the total number of subjects with histology results of less than CIN2.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Positive Predictive Value (PPV) of the BD HPV Assay with 95% confidence intervals for detecting cervical disease as defined by Cervical Intraepithelial Neoplasia (CIN2) or higher.</measure>
    <time_frame>Nine months</time_frame>
    <description>Positive Predictive Value is calculated: Number of subjects with a positive BD HPV test and with histology results of CIN2 or greater divided by the total number of subjects with a positive BD HPV test.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Negative Predictive Value (NPV) of the BD HPV Assay with 95% confidence intervals for detecting cervical disease as defined by Cervical Intraepithelial Neoplasia (CIN2) or higher.</measure>
    <time_frame>Nine months</time_frame>
    <description>Negative Predictive Value is calculated: Number of subjects with a negative result for the BD HPV test and histology results less than CIN2 divided by the total number of subjects with negative results for the BD HPV test.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The positive percent agreement of the BD HPV Assay compared to digene hybrid capture (HC2) test and Roche LINEAR ARRAY HPV Genotyping Test</measure>
    <time_frame>9 months</time_frame>
    <description>Positive percent agreement is calculated: The number of subjects with positive BD HPV test and positive results for the HC2 test and Roche Linear Array HPV divided by total of subjects with positive results for HC2 test and Roche Linear Array HPV.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Negative percent agreement of the BD HPV Assay compared to digene hybrid capture (HC2) test and Roche LINEAR ARRAY HPV Genotyping Test</measure>
    <time_frame>Nine months</time_frame>
    <description>Negative percent agreement is calculated: The number of subjects with negative BD HPV test and negative results for the HC2 test and Roche Linear Array HPV divided by total of subjects with negative results for HC2 test and Roche Linear Array HPV test.</description>
  </secondary_outcome>
  <enrollment type="Actual">1365</enrollment>
  <condition>Uterine Cervical Neoplasms</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>BD HPV assay on Viper LT</intervention_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study includes retrospectively (residual, frozen) collected SurePath or PreservCyt&#xD;
        vials and prospectively collected BD cervical brushes in BD transport medium, and SurePath&#xD;
        or PreservCyt vials from subjects who meet the inclusion criteria below.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Referred to follow up due to one or more abnormal Pap or an HPV infection&#xD;
&#xD;
          -  Subjects who have provided informed consent&#xD;
&#xD;
          -  Subjects who meet the minimum age set forth by the ethics committee (EC) and/or&#xD;
             national screening guidelines.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known to be pregnant&#xD;
&#xD;
          -  With prior complete or partial hysterectomy involving removal of cervix&#xD;
&#xD;
          -  Subjects with an application of chemical compounds to the cervical area 24 hour prior&#xD;
             to study entry- this includes acetic acid, iodine, spermicide, douche, anti-fungal&#xD;
             meds.&#xD;
&#xD;
          -  Subjects on who conization, Loop electrosurgical excision procedure (LEEP), laser&#xD;
             surgery or cryosurgery has been performed.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Irene Hannet, MD</last_name>
    <role>Study Director</role>
    <affiliation>Becton, Dickinson and Company</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hvidovre Hospital</name>
      <address>
        <city>Hvidovre</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>European Institute of Oncology</name>
      <address>
        <city>Milan</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
    <country>Italy</country>
  </location_countries>
  <verification_date>February 2014</verification_date>
  <study_first_submitted>July 13, 2012</study_first_submitted>
  <study_first_submitted_qc>August 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 23, 2012</study_first_posted>
  <last_update_submitted>February 19, 2014</last_update_submitted>
  <last_update_submitted_qc>February 19, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 20, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>HPV</keyword>
  <keyword>Cervical Cancer</keyword>
  <keyword>Cervical Neoplasms</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Uterine Cervical Neoplasms</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/NCT01671462
org study id: MDX-11-EUHPV
nct id: NCT01671462
lead sponsor: 
has dmc: No
The purpose of the study is to compare the results of the Becton Dickinson (BD) Human
      Papilloma Virus (HPV) Assay on the Viper LT instrument from SurePath media diluted in HPV
      diluent (pre-quot and/or residual), PreservCyt media diluted in HPV diluent (pre-quot and/or
      residual) and a BD cervical brush in BD transport medium to reference histology results from
      biopsy.
This is a multicenter study consisting of 2-3 European clinical trial sites, and up to 2 BD
      Viper LT Systems.

      The BD HPV Diluent tube will be run on the BD HPV assay with the Viper LT instrument and
      compared to histology, Digene hybrid capture 2 (HC2), and Roche LINEAR ARRAY HPV Genotyping
      Test results.
measure: Sensitivity of the BD HPV Assay with 95% confidence intervals for detecting cervical disease as defined by Cervical Intraepithelial Neoplasia (CIN2) or higher.
time frame: Nine months
description: Sensitivity is calculated: Number of subjects with positive BD HPV test and with histology results of CIN2 or greater divided by the total number of subjects with histology results of CIN2 or greater
measure: Specificity of the BD HPV Assay with 95% confidence intervals for detecting cervical disease as defined by Cervical Intraepithelial Neoplasia (CIN2) or higher.
time frame: Nine months
description: Specificity is calculated: Number of subjects with a negative BD HPV test and with histology results of less than CIN2 divided by the total number of subjects with histology results of less than CIN2.
measure: Positive Predictive Value (PPV) of the BD HPV Assay with 95% confidence intervals for detecting cervical disease as defined by Cervical Intraepithelial Neoplasia (CIN2) or higher.
time frame: Nine months
description: Positive Predictive Value is calculated: Number of subjects with a positive BD HPV test and with histology results of CIN2 or greater divided by the total number of subjects with a positive BD HPV test.
measure: Negative Predictive Value (NPV) of the BD HPV Assay with 95% confidence intervals for detecting cervical disease as defined by Cervical Intraepithelial Neoplasia (CIN2) or higher.
time frame: Nine months
description: Negative Predictive Value is calculated: Number of subjects with a negative result for the BD HPV test and histology results less than CIN2 divided by the total number of subjects with negative results for the BD HPV test.
measure: The positive percent agreement of the BD HPV Assay compared to digene hybrid capture (HC2) test and Roche LINEAR ARRAY HPV Genotyping Test
time frame: 9 months
description: Positive percent agreement is calculated: The number of subjects with positive BD HPV test and positive results for the HC2 test and Roche Linear Array HPV divided by total of subjects with positive results for HC2 test and Roche Linear Array HPV.
measure: Negative percent agreement of the BD HPV Assay compared to digene hybrid capture (HC2) test and Roche LINEAR ARRAY HPV Genotyping Test
time frame: Nine months
description: Negative percent agreement is calculated: The number of subjects with negative BD HPV test and negative results for the HC2 test and Roche Linear Array HPV divided by total of subjects with negative results for HC2 test and Roche Linear Array HPV test.
intervention type: Device
intervention name: BD HPV assay on Viper LT
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Irene Hannet, MD
role: Study Director
affiliation: Becton, Dickinson and Company
facility: 
facility: 
country: Denmark
country: Italy
responsible party type: Sponsor
mesh term: Uterine Cervical Neoplasms