<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/NCT02226315</url>
  </required_header>
  <id_info>
    <org_study_id>SQNM-T21-109</org_study_id>
    <nct_id>NCT02226315</nct_id>
  </id_info>
  <brief_title>Clinical Performance of the MaterniT21 PLUS LDT in Multiple Gestation Pregnancies</brief_title>
  <official_title>A Retrospective Analysis of Fetal Outcome Compared to Massively Parallel Sequencing Test Results Obtained From Multiple Gestation Pregnancies at Increased Risk for Fetal Chromosomal Aneuploidy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sequenom, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Friends Research Institute, Inc.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Sequenom, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will evaluate the clinical performance of massively parallel sequencing (MPS)&#xD;
      using the MaterniT21 PLUS LDT in the detection of fetal aneuploidy in circulating cfDNA&#xD;
      extracted from a maternal blood sample obtained from women pregnant with a multiple gestation&#xD;
      who were at increased risk for fetal aneuploidy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Slow enrollment of eligible subjects&#xD;
  </why_stopped>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">September 2015</completion_date>
  <primary_completion_date type="Actual">September 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical Performance (Sensitivity/Specificity) of MaterniT21 PLUS LDT Assay</measure>
    <time_frame>Subjects contacted within 3 years after pregnancy is completed</time_frame>
    <description>Results of the MaterniT21 PLUS LDT will be compared to the pregnancy outcome data obtained from the patient</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">50</enrollment>
  <condition>Down Syndrome</condition>
  <condition>Edwards Syndrome</condition>
  <condition>Patau Syndrome</condition>
  <condition>Turner Syndrome</condition>
  <arm_group>
    <arm_group_label>Multiple gestations</arm_group_label>
    <description>Women with a multiple gestation who were evaluated with the MaterniT21 PLUS LDT and have passed their Estimated Date of Delivery (EDD).</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Some subjects will be asked to provide a buccal cell sample for sequencing.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Women with a multiple gestation who were evaluated with the MaterniT21 PLUS LDT and have&#xD;
        passed their Estimated Date of Delivery (EDD).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject was pregnant with a multiple gestation and received NIPT with the MaterniT21&#xD;
             PLUS LDT and a valid test result is available;&#xD;
&#xD;
          -  Subject was 18 years of age or older at the time of NIPT;&#xD;
&#xD;
          -  Subject provides signed and dated informed consent in English;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects' treating physician is not located in the United States.&#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>Richard Porreco, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Presbyterian/St. Luke's Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Presbyterian/St. Luke's Medical Center</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80218</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2015</verification_date>
  <study_first_submitted>August 20, 2014</study_first_submitted>
  <study_first_submitted_qc>August 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2014</study_first_posted>
  <last_update_submitted>September 15, 2015</last_update_submitted>
  <last_update_submitted_qc>September 15, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 17, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>noninvasive prenatal testing</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>Turner Syndrome</mesh_term>
    <mesh_term>Trisomy 18 Syndrome</mesh_term>
    <mesh_term>Syndrome</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/NCT02226315
org study id: SQNM-T21-109
nct id: NCT02226315
lead sponsor: 
collaborator: 
has dmc: No
This study will evaluate the clinical performance of massively parallel sequencing (MPS)
      using the MaterniT21 PLUS LDT in the detection of fetal aneuploidy in circulating cfDNA
      extracted from a maternal blood sample obtained from women pregnant with a multiple gestation
      who were at increased risk for fetal aneuploidy.
observational model: Case-Only
time perspective: Retrospective
measure: Clinical Performance (Sensitivity/Specificity) of MaterniT21 PLUS LDT Assay
time frame: Subjects contacted within 3 years after pregnancy is completed
description: Results of the MaterniT21 PLUS LDT will be compared to the pregnancy outcome data obtained from the patient
arm group label: Multiple gestations
description: Women with a multiple gestation who were evaluated with the MaterniT21 PLUS LDT and have passed their Estimated Date of Delivery (EDD).
Some subjects will be asked to provide a buccal cell sample for sequencing.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Richard Porreco, MD
role: Principal Investigator
affiliation: Presbyterian/St. Luke's Medical Center
facility: 
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