<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/NCT01708746</url>
  </required_header>
  <id_info>
    <org_study_id>VER-0008</org_study_id>
    <nct_id>NCT01708746</nct_id>
  </id_info>
  <brief_title>Investigation of the Impact of Noninvasive Prenatal Testing for Fetal Aneuploidy on Utilization of Prenatal Diagnostic Procedures and Pregnant Women's Views</brief_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, single-institution observational study to be conducted at 4 clinics&#xD;
      within the Southern California Permanente Medical Group. Pregnant women who present for&#xD;
      prenatal genetic counseling at the designated clinics and who meet study eligibility criteria&#xD;
      will be offered the option of the verifi® prenatal test by a trained, licensed and certified&#xD;
      genetic counselor (GC) . Women who elect the verifi® prenatal test will have a blood sample&#xD;
      drawn by peripheral venipuncture that will be sent to the Verinata Health CAP-accredited&#xD;
      clinical laboratory (Redwood City, CA). Results will be reported to the ordering health care&#xD;
      provider by the laboratory within 8-10 business days and will be shared with the subject by&#xD;
      their provider. Subject care and decision-making following NIPT result will be clinically&#xD;
      managed by the provider with his/her subject and is not dictated by the study protocol. All&#xD;
      eligible women who provide informed consent, whether they elect or decline NIPT will be asked&#xD;
      to complete a short questionnaire on their views of prenatal testing. The uptake of invasive&#xD;
      prenatal procedures (CVS and/or amniocentesis) by the total prospective cohort will be&#xD;
      collected through review of electronic medical records (EMR). A historical cohort with&#xD;
      matched demographic and pre-test indications to the prospective cohort will be identified&#xD;
      from the EMR for comparison in the primary analysis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">October 2013</completion_date>
  <primary_completion_date type="Actual">September 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Invasive prenatal procedures rate measure by the occurance of chorionic villus sampling (CVS) and/or amniocentesis</measure>
    <time_frame>Enrolled women will be evaluated on or before Gestational Age: Wk 28</time_frame>
    <description>The primary objective of this study is to compare the rate of uptake of invasive prenatal procedures (chorionic villus sampling (CVS) or amniocentesis) between a prospectively enrolled cohort of pregnant women at high-risk for fetal aneuploidy who are offered noninvasive prenatal testing (NIPT; verifi® prenatal test) and a historical cohort matched for demographics and pre-test risk indications. The prospective group will include both those who accept NIPT and those who decline NIPT, but are willing to consent and complete a brief questionnaire.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Preferences of pregnant women on prenatal testing by completion of preference questionnaire.</measure>
    <time_frame>Evaluated at time of enrollment</time_frame>
    <description>The secondary objective is to collect views/preferences of pregnant women on prenatal testing for fetal chromosomal abnormalities and compare results of eligible women who accept versus those who decline NIPT during the enrollment period.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">205</enrollment>
  <condition>High Risk Pregnancy</condition>
  <arm_group>
    <arm_group_label>Enrolled subjects</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Historic control</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        The study population is comprised of pregnant women at least 18 years of age, who meet the&#xD;
        inclusion criteria but none of the exclusion criteria described below. Women who present&#xD;
        for prenatal genetic counseling at one of the designated study clinics will be recruited.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  Age 18 years or older at enrollment&#xD;
&#xD;
          -  Clinically confirmed singleton pregnancy&#xD;
&#xD;
          -  Gestational age between 10 weeks, 0 days and 20 weeks, 0 days&#xD;
&#xD;
          -  Referred for prenatal genetic counseling due to increased risk for fetal aneuploidy&#xD;
             (advanced maternal age (AMA ≥ 35 years at delivery, high-risk prenatal screen result,&#xD;
             abnormal fetal ultrasound finding consistent with fetal aneuploidy, and/or history of&#xD;
             prior affected pregnancy for fetal aneuploidy)&#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;
             infant 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) already performed&#xD;
&#xD;
          -  History of demised or vanished co-twin (spontaneous or following in vitro&#xD;
             fertilization)&#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>George E Tiller, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kaiser Permanente, Dept Genetics</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Southern California Kaiser Permanente Medical Group</name>
      <address>
        <city>Baldwin Park</city>
        <state>California</state>
        <zip>91706</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southern California Kaiser Permanente Medical Group</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90027</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southern California Kaiser Permanente Medical Group</name>
      <address>
        <city>Panorama City</city>
        <state>California</state>
        <zip>94102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southern California Kaiser Permanente Medical Center</name>
      <address>
        <city>Woodland Hills</city>
        <state>California</state>
        <zip>91367</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Bianchi DW, Platt LD, Goldberg JD, Abuhamad AZ, Sehnert AJ, Rava RP; MatErnal BLood IS Source to Accurately diagnose fetal aneuploidy (MELISSA) Study Group. Genome-wide fetal aneuploidy detection by maternal plasma DNA sequencing. Obstet Gynecol. 2012 May;119(5):890-901. doi: 10.1097/AOG.0b013e31824fb482. Erratum In: Obstet Gynecol. 2012 Oct;120(4):957.</citation>
    <PMID>22362253</PMID>
  </results_reference>
  <results_reference>
    <citation>Sehnert AJ, Rhees B, Comstock D, de Feo E, Heilek G, Burke J, Rava RP. Optimal detection of fetal chromosomal abnormalities by massively parallel DNA sequencing of cell-free fetal DNA from maternal blood. Clin Chem. 2011 Jul;57(7):1042-9. doi: 10.1373/clinchem.2011.165910. Epub 2011 Apr 25.</citation>
    <PMID>21519036</PMID>
  </results_reference>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>October 15, 2012</study_first_submitted>
  <study_first_submitted_qc>October 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 17, 2012</study_first_posted>
  <last_update_submitted>September 24, 2014</last_update_submitted>
  <last_update_submitted_qc>September 24, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 26, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT01708746
org study id: VER-0008
nct id: NCT01708746
lead sponsor: 
has dmc: No
This is a prospective, single-institution observational study to be conducted at 4 clinics
      within the Southern California Permanente Medical Group. Pregnant women who present for
      prenatal genetic counseling at the designated clinics and who meet study eligibility criteria
      will be offered the option of the verifi® prenatal test by a trained, licensed and certified
      genetic counselor (GC) . Women who elect the verifi® prenatal test will have a blood sample
      drawn by peripheral venipuncture that will be sent to the Verinata Health CAP-accredited
      clinical laboratory (Redwood City, CA). Results will be reported to the ordering health care
      provider by the laboratory within 8-10 business days and will be shared with the subject by
      their provider. Subject care and decision-making following NIPT result will be clinically
      managed by the provider with his/her subject and is not dictated by the study protocol. All
      eligible women who provide informed consent, whether they elect or decline NIPT will be asked
      to complete a short questionnaire on their views of prenatal testing. The uptake of invasive
      prenatal procedures (CVS and/or amniocentesis) by the total prospective cohort will be
      collected through review of electronic medical records (EMR). A historical cohort with
      matched demographic and pre-test indications to the prospective cohort will be identified
      from the EMR for comparison in the primary analysis.
observational model: Case-Control
time perspective: Prospective
measure: Invasive prenatal procedures rate measure by the occurance of chorionic villus sampling (CVS) and/or amniocentesis
time frame: Enrolled women will be evaluated on or before Gestational Age: Wk 28
description: The primary objective of this study is to compare the rate of uptake of invasive prenatal procedures (chorionic villus sampling (CVS) or amniocentesis) between a prospectively enrolled cohort of pregnant women at high-risk for fetal aneuploidy who are offered noninvasive prenatal testing (NIPT; verifi® prenatal test) and a historical cohort matched for demographics and pre-test risk indications. The prospective group will include both those who accept NIPT and those who decline NIPT, but are willing to consent and complete a brief questionnaire.
measure: Preferences of pregnant women on prenatal testing by completion of preference questionnaire.
time frame: Evaluated at time of enrollment
description: The secondary objective is to collect views/preferences of pregnant women on prenatal testing for fetal chromosomal abnormalities and compare results of eligible women who accept versus those who decline NIPT during the enrollment period.
arm group label: Enrolled subjects
arm group label: Historic control
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: George E Tiller, MD, PhD
role: Principal Investigator
affiliation: Kaiser Permanente, Dept Genetics
facility: 
facility: 
facility: 
facility: 
country: United States
citation: Bianchi DW, Platt LD, Goldberg JD, Abuhamad AZ, Sehnert AJ, Rava RP; MatErnal BLood IS Source to Accurately diagnose fetal aneuploidy (MELISSA) Study Group. Genome-wide fetal aneuploidy detection by maternal plasma DNA sequencing. Obstet Gynecol. 2012 May;119(5):890-901. doi: 10.1097/AOG.0b013e31824fb482. Erratum In: Obstet Gynecol. 2012 Oct;120(4):957.
PMID: 22362253
citation: Sehnert AJ, Rhees B, Comstock D, de Feo E, Heilek G, Burke J, Rava RP. Optimal detection of fetal chromosomal abnormalities by massively parallel DNA sequencing of cell-free fetal DNA from maternal blood. Clin Chem. 2011 Jul;57(7):1042-9. doi: 10.1373/clinchem.2011.165910. Epub 2011 Apr 25.
PMID: 21519036
responsible party type: Sponsor