<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/NCT04488393</url>
  </required_header>
  <id_info>
    <org_study_id>SCMM-T21-110</org_study_id>
    <nct_id>NCT04488393</nct_id>
  </id_info>
  <brief_title>Clinical Performance of NIPT in Multiple Gestation Pregnancies</brief_title>
  <official_title>Clinical Performance of NIPT (Noninvasive Prenatal Testing) in Multiple Gestation Pregnancies (SCMM-T21-110)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pennsylvania</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sequenom, Inc/Laboratory Corporation of America Holdings</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Pennsylvania</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study plans to evaluate the clinical performance of the MaterniT21 PLUS and/or GENOME&#xD;
      Laboratory Developed Test, in the detection of fetal trisomy 21 in circulating cell-free DNA&#xD;
      extracted from maternal blood samples obtained from women pregnant with a twin gestation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2020</start_date>
  <completion_date type="Actual">June 19, 2022</completion_date>
  <primary_completion_date type="Actual">November 15, 2021</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Determination of sensitivity of NIPT detection of trisomy 21 among a population of women with twin gestations.</measure>
    <time_frame>time from maternal blood draw to delivery</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Determination of specificity of NIPT detection of trisomy 21 among a population of women with twin gestations.</measure>
    <time_frame>time from maternal blood draw to delivery</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">2000</enrollment>
  <condition>Trisomy 21 in Fetus</condition>
  <arm_group>
    <arm_group_label>Pregnancies with multiple gestations</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MaterniT21 PLUS and GENOME Laboratory-Developed Tests</intervention_name>
    <description>Both the MaterniT21 PLUS and GENOME are intended for use as laboratory developed test that analyze ccfDNA extracted from a maternal blood sample utilizing Massively Parallel Sequencing (MPS) technology.</description>
    <arm_group_label>Pregnancies with multiple gestations</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The Study Population will consist of women 18 years of age and older who underwent testing&#xD;
        with a Sequenom NIPT, were pregnant with a multiple gestation at the time of testing and&#xD;
        whose pregnancies should have outcome based upon gestational age at the time of testing.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  subject pregnant with a multiple gestation and received NIPT from Sequenom&#xD;
             Laboratories;&#xD;
&#xD;
          -  subject was 18 or older at the time of NIPT&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  none&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>July 22, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2020</study_first_posted>
  <last_update_submitted>December 5, 2022</last_update_submitted>
  <last_update_submitted_qc>December 5, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 7, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Pennsylvania</investigator_affiliation>
    <investigator_full_name>Lorraine Dugoff</investigator_full_name>
    <investigator_title>Professor of Obstetrics and Gynecology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Down Syndrome</mesh_term>
    <mesh_term>Trisomy</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04488393
org study id: SCMM-T21-110
nct id: NCT04488393
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study plans to evaluate the clinical performance of the MaterniT21 PLUS and/or GENOME
      Laboratory Developed Test, in the detection of fetal trisomy 21 in circulating cell-free DNA
      extracted from maternal blood samples obtained from women pregnant with a twin gestation.
observational model: Cohort
time perspective: Retrospective
measure: Determination of sensitivity of NIPT detection of trisomy 21 among a population of women with twin gestations.
time frame: time from maternal blood draw to delivery
measure: Determination of specificity of NIPT detection of trisomy 21 among a population of women with twin gestations.
time frame: time from maternal blood draw to delivery
arm group label: Pregnancies with multiple gestations
intervention type: Device
intervention name: MaterniT21 PLUS and GENOME Laboratory-Developed Tests
description: Both the MaterniT21 PLUS and GENOME are intended for use as laboratory developed test that analyze ccfDNA extracted from a maternal blood sample utilizing Massively Parallel Sequencing (MPS) technology.
arm group label: Pregnancies with multiple gestations
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Pennsylvania
investigator full name: Lorraine Dugoff
investigator title: Professor of Obstetrics and Gynecology
mesh term: Down Syndrome
mesh term: Trisomy
sharing ipd: No