<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/NCT01728103</url>
  </required_header>
  <id_info>
    <org_study_id>ATVTS-US12-001</org_study_id>
    <secondary_id>AC2PS-US12-002</secondary_id>
    <secondary_id>ATVPS-US12-001</secondary_id>
    <secondary_id>ATVTS-US12-003</secondary_id>
    <nct_id>NCT01728103</nct_id>
  </id_info>
  <brief_title>Prospective Collection of Female Specimens for Testing With Gen-Probe APTIMA (Registered Trademark) Assays</brief_title>
  <official_title>Prospective Collection of Female First-catch Urine, Vaginal Swab,Cervical, and Endocervical Swab Specimens for Testing With the APTIMA Assays</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 obtain female first-catch urine, vaginal, cervical and&#xD;
      endocervical swabs for testing with multiple APTIMA Assays on the Gen-Probe PANTHER® and&#xD;
      TIGRIS® Systems.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Corporate decision to spend money on other development programs.&#xD;
  </why_stopped>
  <start_date>January 2013</start_date>
  <primary_completion_date type="Actual">July 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 Chlamydia trachomatis and/or Neisseria gonorrhoeae (NG) and Trichomonas vaginalis (TV) to aid in the diagnosis of chlamydial and/or gonococcal and/or trichomonal urogenital disease</measure>
    <time_frame>approximately one year</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1336</enrollment>
  <condition>Chlamydia Infections</condition>
  <condition>Gonorrhea</condition>
  <condition>Trichomonas Infections</condition>
  <arm_group>
    <arm_group_label>No Treatment</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>APTIMA® Trichomonas vaginalis &amp; APTIMA® COMBO 2® Assays</intervention_name>
    <description>In Vitro Diagnostic Assays</description>
    <arm_group_label>No Treatment</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      urine; endocervical and vaginal swabs&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Female subjects at least 16 years of age, with or without symptoms of sexually transmitted&#xD;
        disease.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The subject is at least 16 years of age at the time of enrollment and is currently&#xD;
             sexually active (has had penile/vaginal intercourse within the past 12 months)&#xD;
&#xD;
          -  The subject and/or legally authorized representative is willing to undergo the&#xD;
             informed consent process prior to study participation (a minor will need the&#xD;
             documented consent of his/her parent or legal guardian, unless the site has an&#xD;
             institutional review board [IRB]-approved waiver for parental consent for minors)&#xD;
&#xD;
        In addition, the subject must meet at least one of the following criteria:&#xD;
&#xD;
          -  The subject reports symptoms consistent with a suspected sexually transmissible&#xD;
             infection (STI) such as abnormal discharge, genital itching, pain/discomfort during&#xD;
             sexual intercourse or urination, and/or lower abdominal discomfort&#xD;
&#xD;
          -  Subject is asymptomatic and known to be partners with, or a contact of, a person with&#xD;
             a confirmed or suspected STI(s)&#xD;
&#xD;
          -  Subject is asymptomatic and undergoing screening evaluation for possible STIs&#xD;
&#xD;
          -  Subject is asymptomatic and undergoing a routine examination with a pelvic examination&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The subject took antibiotic medications within the last 21 days&#xD;
&#xD;
          -  Subject already participated in this study&#xD;
&#xD;
          -  Subject has a history of illness that the principal investigator (PI) or designee&#xD;
             considers could interfere with or affect the conduct, results, and/or completion of&#xD;
             the clinical trial&#xD;
&#xD;
          -  Subject has a history of illness that the PI or designee considers could create an&#xD;
             unacceptable risk to the subject if enrolled&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Renee Wait</last_name>
    <role>Study Director</role>
    <affiliation>Gen-Probe, Incorporated</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Infectious Diseases STD Program University of Alabama at Birmingham</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35294</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Center for Clinical Research</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Healthcare Clinical Data</name>
      <address>
        <city>North Miami</city>
        <state>Florida</state>
        <zip>33161</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mount Vernon Clinical Research</name>
      <address>
        <city>Sandy Springs</city>
        <state>Georgia</state>
        <zip>30328</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Louisiana State University Health Sciences Center Dept. of Medicine, Infectious Disease</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>John Hopkins University</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New England Center for Clinical Research</name>
      <address>
        <city>Fall River</city>
        <state>Massachusetts</state>
        <zip>02720</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of North Carolina Chapel Hill</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599-7030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cincinnati Children's Hospital Medical Center Division of Pediatric &amp; Adolescent Gynecology</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45229-3039</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Planned Parenthood Southeastern Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical University of South Carolina</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Jackson Clinic</name>
      <address>
        <city>Jackson</city>
        <state>Tennessee</state>
        <zip>38305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Planned Parenthood Gulf Coast</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77023</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tidewater Clinical Research</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>November 12, 2012</study_first_submitted>
  <study_first_submitted_qc>November 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 16, 2012</study_first_posted>
  <last_update_submitted>August 14, 2017</last_update_submitted>
  <last_update_submitted_qc>August 14, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 16, 2017</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>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Chlamydia Infections</mesh_term>
    <mesh_term>Gonorrhea</mesh_term>
    <mesh_term>Trichomonas 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/NCT01728103
org study id: ATVTS-US12-001
secondary id: AC2PS-US12-002
secondary id: ATVPS-US12-001
secondary id: ATVTS-US12-003
nct id: NCT01728103
lead sponsor: 
has dmc: No
The objective of this study is to obtain female first-catch urine, vaginal, cervical and
      endocervical swabs for testing with multiple APTIMA Assays on the Gen-Probe PANTHER® and
      TIGRIS® Systems.
observational model: Cohort
time perspective: Prospective
measure: Qualitative detection of ribosomal RNA from Chlamydia trachomatis and/or Neisseria gonorrhoeae (NG) and Trichomonas vaginalis (TV) to aid in the diagnosis of chlamydial and/or gonococcal and/or trichomonal urogenital disease
time frame: approximately one year
arm group label: No Treatment
intervention type: Device
intervention name: APTIMA® Trichomonas vaginalis & APTIMA® COMBO 2® Assays
description: In Vitro Diagnostic Assays
arm group label: No Treatment
urine; endocervical and vaginal swabs
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 16 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Renee Wait
role: Study Director
affiliation: Gen-Probe, Incorporated
facility: 
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country: United States
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Chlamydia Infections
mesh term: Gonorrhea
mesh term: Trichomonas Infections