<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/NCT02201862</url>
  </required_header>
  <id_info>
    <org_study_id>AD201</org_study_id>
    <nct_id>NCT02201862</nct_id>
  </id_info>
  <brief_title>Non-Invasive Chromosomal Evaluation of Trisomy Study</brief_title>
  <acronym>NICHE</acronym>
  <official_title>Non-Invasive Chromosomal Evaluation of Trisomy Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cindy Cisneros</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Roche Sequencing Solutions</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is being conducted to provide clinically annotated samples to support continued&#xD;
      improvements in the Ariosa Test content, methodology, specimen processing and quality&#xD;
      control.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 2014</start_date>
  <completion_date type="Actual">August 1, 2019</completion_date>
  <primary_completion_date type="Actual">August 1, 2019</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>Detection of aneuploidy</measure>
    <time_frame>24 months</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">2000</enrollment>
  <condition>Aneuploidy</condition>
  <condition>Trisomy 21</condition>
  <condition>Trisomy 18</condition>
  <condition>Trisomy 13</condition>
  <condition>Down Syndrome</condition>
  <arm_group>
    <arm_group_label>Euploid Subjects</arm_group_label>
    <description>Subject's with fetal euploidy confirmed by chromosome analysis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Aneuploid Subjects</arm_group_label>
    <description>Subject's with fetal aneuploidy confirmed by chromosome analysis</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Plasma&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Pregnant women planning to undergo chorionic villus sampling (CVS) and/or amniocentesis for&#xD;
        the purpose of genetic evaluation of the fetus.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1. Subject is at least 18 years old and can provide informed consent;&#xD;
&#xD;
          -  2. Subject has a viable singleton or twin pregnancy;&#xD;
&#xD;
          -  3. Subject is confirmed to be at least 10 weeks, 0 days gestation at the time of the&#xD;
             study blood draw;&#xD;
&#xD;
          -  4. Subject is planning to undergo CVS and/or amniocentesis for the purpose of genetic&#xD;
             analysis of the fetus OR the subject has already undergone CVS and/or amniocentesis&#xD;
             and is known to have a fetus with a chromosomal abnormality confirmed by genetic&#xD;
             analysis.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1. Subject has known aneuploidy;&#xD;
&#xD;
          -  2. Subject is pregnant with more than two fetuses or has had sonographic evidence of&#xD;
             three or more gestational sacs at any time during pregnancy;&#xD;
&#xD;
          -  3. Subject has a fetal demise (including natural or elective reduction) identified&#xD;
             prior to consent;&#xD;
&#xD;
          -  4. Subject has history of malignancy treated with chemotherapy and/or major surgery,&#xD;
             or bone marrow transplant;&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University California San Diego</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Women's Healthcare Group of PA</name>
      <address>
        <city>Oaks</city>
        <state>Pennsylvania</state>
        <zip>19456</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regional Obestrical Consultants</name>
      <address>
        <city>Chattanooga</city>
        <state>Tennessee</state>
        <zip>37403</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Norton ME, Brar H, Weiss J, Karimi A, Laurent LC, Caughey AB, Rodriguez MH, Williams J 3rd, Mitchell ME, Adair CD, Lee H, Jacobsson B, Tomlinson MW, Oepkes D, Hollemon D, Sparks AB, Oliphant A, Song K. Non-Invasive Chromosomal Evaluation (NICE) Study: results of a multicenter prospective cohort study for detection of fetal trisomy 21 and trisomy 18. Am J Obstet Gynecol. 2012 Aug;207(2):137.e1-8. doi: 10.1016/j.ajog.2012.05.021. Epub 2012 Jun 1.</citation>
    <PMID>22742782</PMID>
  </reference>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>July 22, 2014</study_first_submitted>
  <study_first_submitted_qc>July 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 28, 2014</study_first_posted>
  <last_update_submitted>April 28, 2020</last_update_submitted>
  <last_update_submitted_qc>April 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Roche Sequencing Solutions</investigator_affiliation>
    <investigator_full_name>Cindy Cisneros</investigator_full_name>
    <investigator_title>CRA</investigator_title>
  </responsible_party>
  <keyword>Aneuploidy</keyword>
  <keyword>Down Syndrome</keyword>
  <keyword>amniocentesis</keyword>
  <keyword>chronic villus sampling</keyword>
  <keyword>Trisomy</keyword>
  <keyword>non-invasive prenatal testing</keyword>
  <keyword>Chromosome disorders</keyword>
  <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>Trisomy 18 Syndrome</mesh_term>
    <mesh_term>Aneuploidy</mesh_term>
    <mesh_term>Trisomy</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/NCT02201862
org study id: AD201
nct id: NCT02201862
lead sponsor: 
has dmc: No
This study is being conducted to provide clinically annotated samples to support continued
      improvements in the Ariosa Test content, methodology, specimen processing and quality
      control.
observational model: Case-Control
time perspective: Prospective
measure: Detection of aneuploidy
time frame: 24 months
arm group label: Euploid Subjects
description: Subject's with fetal euploidy confirmed by chromosome analysis
arm group label: Aneuploid Subjects
description: Subject's with fetal aneuploidy confirmed by chromosome analysis
Plasma
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
facility: 
country: United States
citation: Norton ME, Brar H, Weiss J, Karimi A, Laurent LC, Caughey AB, Rodriguez MH, Williams J 3rd, Mitchell ME, Adair CD, Lee H, Jacobsson B, Tomlinson MW, Oepkes D, Hollemon D, Sparks AB, Oliphant A, Song K. Non-Invasive Chromosomal Evaluation (NICE) Study: results of a multicenter prospective cohort study for detection of fetal trisomy 21 and trisomy 18. Am J Obstet Gynecol. 2012 Aug;207(2):137.e1-8. doi: 10.1016/j.ajog.2012.05.021. Epub 2012 Jun 1.
PMID: 22742782
responsible party type: Sponsor-Investigator
investigator affiliation: Roche Sequencing Solutions
investigator full name: Cindy Cisneros
investigator title: CRA
mesh term: Down Syndrome
mesh term: Trisomy 13 Syndrome
mesh term: Trisomy 18 Syndrome
mesh term: Aneuploidy
mesh term: Trisomy