<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/NCT01663350</url>
  </required_header>
  <id_info>
    <org_study_id>VER-0007</org_study_id>
    <nct_id>NCT01663350</nct_id>
  </id_info>
  <brief_title>Comparison of Aneuploidy Risk Evaluations</brief_title>
  <acronym>CARE</acronym>
  <official_title>Performance of the Verinata Health Prenatal Aneuploidy Test Compared to Current Fetal Aneuploidy Screening Results and Pregnancy Outcomes in an 'All-Risk' Population</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Verinata Health, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Verinata Health, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective, multi-center observational study designed to compare the test results&#xD;
      of the Verinata Health Prenatal Aneuploidy Test to results of conventional prenatal screening&#xD;
      for fetal chromosome abnormalities in 'all-risk' pregnancies.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <primary_completion_date type="Actual">July 2013</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>Comparison of screen positive rates between investigational testing results and conventional screening results (standard of care).</measure>
    <time_frame>12 months</time_frame>
    <description>The primary outcome of this study is the false positive rate of fetal aneuploidy detection for chromosome 21, 18, and 13 by the Verinata Health Prenatal Aneuploidy Test and screen positive rate for fetal trisomy (T21) and trisomy (T18) by conventional prenatal screening methods. Birth outcomes, or karyotype if available, will be used as the reference standard.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">3000</enrollment>
  <condition>Pregnancy</condition>
  <condition>Down Syndrome</condition>
  <condition>Edwards Syndrome</condition>
  <condition>Patau Syndrome</condition>
  <condition>Turners Syndrome</condition>
  <arm_group>
    <arm_group_label>All-risk pregnant women</arm_group_label>
    <description>All-risk pregnancies undergoing conventional forms of prenatal screening</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Plasma&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The study population is comprised of pregnant women at least 18 years of age, who meet the&#xD;
        study eligibility criteria. Women who plan or have already completed prenatal screening for&#xD;
        fetal aneuploidy during first and/or second trimester, will be recruited from approved&#xD;
        participating clinical centers.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 years or older at enrollment&#xD;
&#xD;
          -  Clinically confirmed pregnancy&#xD;
&#xD;
          -  Gestational age ≥8 weeks, 0 days&#xD;
&#xD;
          -  Planned or completed prenatal serum screening* (drawn during 1st and/or 2nd trimester)&#xD;
&#xD;
          -  Pregnancy records accessible and available for data collection (e.g., results from&#xD;
             screening, ultrasound examinations, invasive prenatal procedures if performed, and&#xD;
             newborn hospital discharge exam)&#xD;
&#xD;
          -  Able to provide consent for participation using language appropriate forms&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Invasive prenatal procedure (amniocentesis or CVS) performed within 2 weeks prior to&#xD;
             enrollment&#xD;
&#xD;
          -  Prenatal screening determination by Nuchal Translucency (NT) measurement only&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Amy J Sehnert, MD</last_name>
    <role>Study Director</role>
    <affiliation>Verinata Health, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>West Coast OB/GYN</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AD Williams Laboratory</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Prentice Women's Hospital</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>William Beaumont Hospital</name>
      <address>
        <city>Royal Oak</city>
        <state>Michigan</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Minnesota</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University</name>
      <address>
        <city>St. Louis</city>
        <state>Missouri</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Desert Perinatal Associates</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Peter's University Hospital</name>
      <address>
        <city>New Brunswick</city>
        <state>New Jersey</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virtua Perinatology Associates of Voorhees</name>
      <address>
        <city>Voorhees</city>
        <state>New Jersey</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jacobi Medical Center</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northshore University Hospital</name>
      <address>
        <city>Manhasset</city>
        <state>New York</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Winthrop University Hospital</name>
      <address>
        <city>Mineola</city>
        <state>New York</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Long Island Jewish Medical Center</name>
      <address>
        <city>New Hyde Park</city>
        <state>New York</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mount Sinai Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lyndhurst Clinical Research</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lyndhurst Clinical Research</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maternal Fetal Medicine</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MacDonald Clinical Research Unit</name>
      <address>
        <city>Mayfield Heights</city>
        <state>Ohio</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Network Office of Research and Innovation Lehigh Valley Health Network</name>
      <address>
        <city>Allentown</city>
        <state>Pennsylvania</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical University of South Carolina</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>South Carolina Clinical Research</name>
      <address>
        <city>Columbia</city>
        <state>South Carolina</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Greenville Hospital Systems</name>
      <address>
        <city>Greenville</city>
        <state>South Carolina</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jackson Clinic</name>
      <address>
        <city>Jackson</city>
        <state>Tennessee</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Practice Research Organization</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eastern Virginia Medical School</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Group for Women</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2013</verification_date>
  <study_first_submitted>July 31, 2012</study_first_submitted>
  <study_first_submitted_qc>August 8, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2012</study_first_posted>
  <last_update_submitted>July 12, 2013</last_update_submitted>
  <last_update_submitted_qc>July 12, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 16, 2013</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>Down Syndrome</mesh_term>
    <mesh_term>Trisomy 13 Syndrome</mesh_term>
    <mesh_term>Turner Syndrome</mesh_term>
    <mesh_term>Trisomy 18 Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
    <mesh_term>Aneuploidy</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/NCT01663350
org study id: VER-0007
nct id: NCT01663350
lead sponsor: 
has dmc: No
This is a prospective, multi-center observational study designed to compare the test results
      of the Verinata Health Prenatal Aneuploidy Test to results of conventional prenatal screening
      for fetal chromosome abnormalities in 'all-risk' pregnancies.
observational model: Cohort
time perspective: Prospective
measure: Comparison of screen positive rates between investigational testing results and conventional screening results (standard of care).
time frame: 12 months
description: The primary outcome of this study is the false positive rate of fetal aneuploidy detection for chromosome 21, 18, and 13 by the Verinata Health Prenatal Aneuploidy Test and screen positive rate for fetal trisomy (T21) and trisomy (T18) by conventional prenatal screening methods. Birth outcomes, or karyotype if available, will be used as the reference standard.
arm group label: All-risk pregnant women
description: All-risk pregnancies undergoing conventional forms of prenatal screening
Plasma
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Amy J Sehnert, MD
role: Study Director
affiliation: Verinata Health, Inc.
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country: United States
responsible party type: Sponsor
mesh term: Down Syndrome
mesh term: Trisomy 13 Syndrome
mesh term: Turner Syndrome
mesh term: Trisomy 18 Syndrome
mesh term: Syndrome
mesh term: Aneuploidy