<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/NCT03020121</url>
  </required_header>
  <id_info>
    <org_study_id>BDS-USHPVPC-AC</org_study_id>
    <nct_id>NCT03020121</nct_id>
  </id_info>
  <brief_title>Validation of BD Onclarity™ HPV Assay With PreservCyt® -ASCUS Samples</brief_title>
  <official_title>Validation of BD Onclarity™ HPV Assay With PreservCyt® -ASCUS Samples</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 Liquid-based cytology media&#xD;
      diluted in HPV diluent to adjudicated histology results from biopsy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Lower than anticipated rate of subject enrollment&#xD;
  </why_stopped>
  <start_date>November 2016</start_date>
  <completion_date type="Actual">May 2017</completion_date>
  <primary_completion_date type="Actual">May 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Sensitivity</measure>
    <time_frame>18 months</time_frame>
    <description>Sensitivity of the BD HPV Assay for the detection of cervical disease as defined by Cervical Intraepithelial Neoplasia (CIN). Sensitivity is calculated: Number of subjects with a positive BD HPV test with adjudicated histology results of CIN2 or greater divided by the total number of subjects with adjudicated histology results of CIN2 or greater. Similar for CIN3 or greater.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Specificity</measure>
    <time_frame>18 months</time_frame>
    <description>Specificity of the BD HPV Assay for detecting cervical disease as defined by Cervical Intraepithelial Neoplasia (CIN). Specificity is calculated: Number of subjects with a negative BD HPV test with adjudicated histology results of less than CIN2 divided by the total number of subjects with adjudicated histology results of less than CIN2. Similar for CIN3 or greater.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PositivePredictive Value</measure>
    <time_frame>18 months</time_frame>
    <description>Positive Predictive Value (PPV) of the BD HPV Assay for detecting cervical disease as defined by Cervical Intraepithelial Neoplasia (CIN). Positive Predictive Value is calculated: Number of subjects with a positive result for the BD HPV test and adjudicated histology results of CIN2 or greater divided by the total number of subjects with positive result for the BD HPV test. Similar for CIN3 or greater.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Negative Predictive Value</measure>
    <time_frame>18 Months</time_frame>
    <description>Negative Predictive Value (NPV) of the BD HPV Assay for detecting cervical disease as defined by Cervical Intraepithelial Neoplasia (CIN). 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. Similar for CIN3 or greater.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Likelyhood ratio</measure>
    <time_frame>18 months</time_frame>
    <description>Likelihood ratio for the detection of cervical disease as defined by cervical intraepithelial neoplasia (CIN). The likelihood ratio for each BD HPV test outcome summarizes how many times more (or less) likely subjects with the disease (e.g. CIN2 or greater and CIN3 or greater) are to have that particular HPV test outcome than subjects without the disease.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Absolute Risk</measure>
    <time_frame>18 Months</time_frame>
    <description>Absolute risk for the detection of cervical disease as defined by cervical intraepithelial neoplasia (CIN). The Absolute Risk (AR) of the disease(e.g., CIN2 or greater and CIN3 or greater) for each BD HPV test outcome is the probability of the disease for that particular BD HPV test outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Relative Risk</measure>
    <time_frame>18 Months</time_frame>
    <description>Relative Risk of the detection of cervical disease as defined by cervical intraepithelial neoplasia (CIN). Relative Risk is the ratio between two different absolute risks. The relative risk of having a disease (e.g., CIN2 or greater and CIN3 or greater), will be evaluated to compare two different BD HPV Assay test outcomes.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Positive Percent Agreement</measure>
    <time_frame>18 Months</time_frame>
    <description>Positive percent agreement of the BD HPV Assay as compared to a composite HPV comparator incorporating results for the Digene Hybrid Capture 2 (HC2) HPV test and PCR/Sequencing on both strands of the PCR amplicon (bidirectional sequencing). Positive percent agreement is calculated: Number of subjects with a positive BD HPV test with composite comparator positive divided by the total number of subjects with composite comparator positive.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Negative PercentAgreement</measure>
    <time_frame>18 months</time_frame>
    <description>Negative percent agreement of the BD HPV Assay as compared to a composite HPV comparator incorporating results for the Digene HC2 HPV test and Polymerase Chain Reaction (PCR)/Sequencing on both strands of the PCR amplicon (bidirectional sequencing). Negative percent agreement is calculated: Number of subjects with a negative BD HPV test with composite comparator negative divided by the total number of subjects with composite comparator negative.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Non reportable rate</measure>
    <time_frame>18 months</time_frame>
    <description>.Non-reportable rate of BD HPV test. Non-reportable rate is calculated as the number of non-reportable BD HPV test results divided by the total number of BD HPV test results</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">28</enrollment>
  <condition>Uterine Cervical Neoplasm</condition>
  <arm_group>
    <arm_group_label>BD HPV assay on Viper LT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The BD HPV specimen will be tested with the BD HPV assay on the Viper LT instrument. The results will be compared to adjudicated histology. A portion of the specimens will be compared to a composite comparator generated by results of both Digene HPV and a polymerase chain reaction (PCR) sequencing test.&#xD;
Device: BD HPV assay on Viper LT The BD HPV specimen will be tested with the BD HPV assay on the Viper LT instrument. The results will be compared to adjudicated histology. A portion of the specimens will be compared to a composite comparator generated by results of both Digene HPV and a polymerase chain reaction (PCR) sequencing test. Colposcopy/biopsy will be performed on all subjects.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Colposcopy/biopsy</intervention_name>
    <description>Colposcopy/biopsy will be performed on all subjects</description>
    <arm_group_label>BD HPV assay on Viper LT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Females who are greater than or equal to 21 years of age,&#xD;
&#xD;
          -  Subjects with a ASCUS (Atypical Squamous Cells - Undetermined Significance) cytology&#xD;
             result,&#xD;
&#xD;
          -  Females who provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known pregnant&#xD;
&#xD;
          -  Prior complete or partial hysterectomy involving removal of cervix&#xD;
&#xD;
          -  Conization, LEEP, cervical laser surgery or cryosurgery on the cervix has been&#xD;
             performed in the last twelve months&#xD;
&#xD;
          -  Colposcopy clinic referral patients&#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>
  <location>
    <facility>
      <name>Planned Parenthood of the Rocky Mountains</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>American Pathology Partners Inc.</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80222</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Comprehensive Clinical Trials, LLC</name>
      <address>
        <city>West Palm Beach</city>
        <state>Florida</state>
        <zip>33409</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Indiana University</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sidney &amp; Lois Eskenazi Hospital</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Transgenomics</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68164</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southwest Womens Health</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tricore Reference Lab</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Pathology Associates, LLC</name>
      <address>
        <city>Irvington</city>
        <state>New York</state>
        <zip>10533</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Pathology Associates</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>22901</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center for Disease Detection</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78233</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>BioVision</name>
      <address>
        <city>Outremont</city>
        <state>Quebec</state>
        <zip>H2V 3J11</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>January 11, 2017</study_first_submitted>
  <study_first_submitted_qc>January 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 13, 2017</study_first_posted>
  <last_update_submitted>January 29, 2018</last_update_submitted>
  <last_update_submitted_qc>January 29, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 31, 2018</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>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/NCT03020121
org study id: BDS-USHPVPC-AC
nct id: NCT03020121
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 Liquid-based cytology media
      diluted in HPV diluent to adjudicated histology results from biopsy.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Sensitivity
time frame: 18 months
description: Sensitivity of the BD HPV Assay for the detection of cervical disease as defined by Cervical Intraepithelial Neoplasia (CIN). Sensitivity is calculated: Number of subjects with a positive BD HPV test with adjudicated histology results of CIN2 or greater divided by the total number of subjects with adjudicated histology results of CIN2 or greater. Similar for CIN3 or greater.
measure: Specificity
time frame: 18 months
description: Specificity of the BD HPV Assay for detecting cervical disease as defined by Cervical Intraepithelial Neoplasia (CIN). Specificity is calculated: Number of subjects with a negative BD HPV test with adjudicated histology results of less than CIN2 divided by the total number of subjects with adjudicated histology results of less than CIN2. Similar for CIN3 or greater.
measure: PositivePredictive Value
time frame: 18 months
description: Positive Predictive Value (PPV) of the BD HPV Assay for detecting cervical disease as defined by Cervical Intraepithelial Neoplasia (CIN). Positive Predictive Value is calculated: Number of subjects with a positive result for the BD HPV test and adjudicated histology results of CIN2 or greater divided by the total number of subjects with positive result for the BD HPV test. Similar for CIN3 or greater.
measure: Negative Predictive Value
time frame: 18 Months
description: Negative Predictive Value (NPV) of the BD HPV Assay for detecting cervical disease as defined by Cervical Intraepithelial Neoplasia (CIN). 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. Similar for CIN3 or greater.
measure: Likelyhood ratio
time frame: 18 months
description: Likelihood ratio for the detection of cervical disease as defined by cervical intraepithelial neoplasia (CIN). The likelihood ratio for each BD HPV test outcome summarizes how many times more (or less) likely subjects with the disease (e.g. CIN2 or greater and CIN3 or greater) are to have that particular HPV test outcome than subjects without the disease.
measure: Absolute Risk
time frame: 18 Months
description: Absolute risk for the detection of cervical disease as defined by cervical intraepithelial neoplasia (CIN). The Absolute Risk (AR) of the disease(e.g., CIN2 or greater and CIN3 or greater) for each BD HPV test outcome is the probability of the disease for that particular BD HPV test outcome.
measure: Relative Risk
time frame: 18 Months
description: Relative Risk of the detection of cervical disease as defined by cervical intraepithelial neoplasia (CIN). Relative Risk is the ratio between two different absolute risks. The relative risk of having a disease (e.g., CIN2 or greater and CIN3 or greater), will be evaluated to compare two different BD HPV Assay test outcomes.
measure: Positive Percent Agreement
time frame: 18 Months
description: Positive percent agreement of the BD HPV Assay as compared to a composite HPV comparator incorporating results for the Digene Hybrid Capture 2 (HC2) HPV test and PCR/Sequencing on both strands of the PCR amplicon (bidirectional sequencing). Positive percent agreement is calculated: Number of subjects with a positive BD HPV test with composite comparator positive divided by the total number of subjects with composite comparator positive.
measure: Negative PercentAgreement
time frame: 18 months
description: Negative percent agreement of the BD HPV Assay as compared to a composite HPV comparator incorporating results for the Digene HC2 HPV test and Polymerase Chain Reaction (PCR)/Sequencing on both strands of the PCR amplicon (bidirectional sequencing). Negative percent agreement is calculated: Number of subjects with a negative BD HPV test with composite comparator negative divided by the total number of subjects with composite comparator negative.
measure: Non reportable rate
time frame: 18 months
description: .Non-reportable rate of BD HPV test. Non-reportable rate is calculated as the number of non-reportable BD HPV test results divided by the total number of BD HPV test results
arm group label: BD HPV assay on Viper LT
arm group type: Experimental
description: The BD HPV specimen will be tested with the BD HPV assay on the Viper LT instrument. The results will be compared to adjudicated histology. A portion of the specimens will be compared to a composite comparator generated by results of both Digene HPV and a polymerase chain reaction (PCR) sequencing test.
Device: BD HPV assay on Viper LT The BD HPV specimen will be tested with the BD HPV assay on the Viper LT instrument. The results will be compared to adjudicated histology. A portion of the specimens will be compared to a composite comparator generated by results of both Digene HPV and a polymerase chain reaction (PCR) sequencing test. Colposcopy/biopsy will be performed on all subjects.
intervention type: Procedure
intervention name: Colposcopy/biopsy
description: Colposcopy/biopsy will be performed on all subjects
arm group label: BD HPV assay on Viper LT
criteria: 
gender: Female
minimum age: 21 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Canada
country: United States
responsible party type: Sponsor
mesh term: Uterine Cervical Neoplasms