<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/NCT03831256</url>
  </required_header>
  <id_info>
    <org_study_id>SIRUL 118984</org_study_id>
    <nct_id>NCT03831256</nct_id>
  </id_info>
  <brief_title>PErsonalized Genomics for Prenatal Abnormalities Screening USing Maternal Blood</brief_title>
  <acronym>PEGASUS-2</acronym>
  <official_title>PErsonalized Genomics for Prenatal Abnormalities Screening USing Maternal Blood : Towards First Tier Screening and Beyond</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CHU de Quebec-Universite Laval</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Genome Quebec</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Genome British Columbia</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Genome Alberta</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ontario Research Fund</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Laval University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>St. Justine's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ottawa Hospital Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>McGill University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of British Columbia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Alberta</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Genome Canada</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Canadian Institutes of Health Research (CIHR)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>CHU de Quebec-Universite Laval</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 project aims to provide high- quality evidence to inform decisions by health care&#xD;
      organisations about using first-tier non-invasive prenatal screening (NIPS) to replace&#xD;
      traditional screening tests for trisomy 21, and potentially to screen for other fetal&#xD;
      chromosome anomalies. We will compare the current screening approach of second-tier NIPS with&#xD;
      the use of first-tier NIPS in a large cohort of pregnant women.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There is some data on the performance of NIPS as a first tier screening test but our&#xD;
      systematic review has shown that no trial comparing the effectiveness (utility) of 2nd-tier&#xD;
      NIPS with that of first-tier NIPS has been published . Further it is important for health&#xD;
      care decision makers to have evidence produced in Canada since the geographical context of&#xD;
      healthcare can affect uptake as well as patient decision and thus their healthcare&#xD;
      trajectories. There is a need for a trial that is between an explanatory trial and a&#xD;
      pragmatic trial to provide the types of answer that we aim to document in the present state&#xD;
      of knowledge on NIPS-based screening strategies in Canada. Our Objective is to perform a&#xD;
      pan-Canadian large-scale comparative utility (clinical outcomes) study of first-tier NIPS&#xD;
      (expanded or not) as compared to the new standard of care (NIPS as a 2nd tier test performed&#xD;
      much later during pregnancy and only in high risk pregnancies).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">January 13, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Open-label prospective comparative-effectiveness (utility) randomised trial between first-tier NIPS and the standard of care (2nd-tier NIPS).</intervention_model_description>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Gestational age at diagnosis</measure>
    <time_frame>Up to 24 weeks of gestational age</time_frame>
    <description>gestational age at final result in the sub-set of participants that have received a positive NIPS result and that have been offered diagnostic testing</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Gestational age at negative screening result</measure>
    <time_frame>Up to 24 weeks of gestational age</time_frame>
    <description>gestational age at final result in the sub-set of participants that have received a negative screening result</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gestational age at positive screening result</measure>
    <time_frame>Up to 24 weeks of gestational age</time_frame>
    <description>gestational age at final result in the sub-set of participants that have received a positive screening result</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>proportion of women with no results</measure>
    <time_frame>Up to 24 weeks of gestational age</time_frame>
    <description>proportion of women with no NIPS result at first and second attempt</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>numbers of days for women with false positive result of screen to wait for result of definite test</measure>
    <time_frame>Up to 24 weeks of gestational age</time_frame>
    <description>Difference between gestational age (in days) at first positive prenatal screening result and final negative screening result</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in PROMIS-29 Score</measure>
    <time_frame>At weeks of gestation 10-13, week 16 and week 22</time_frame>
    <description>The PROMIS-29 assesses seven health domains: physical function, anxiety, depression, fatigue, sleep disturbance, pain interference, and ability to participate in social roles and activities. Each of the seven domains has four questions which are scored on a five-point Likert scale. The PROMIS-29 scales will be scored using a T-score metric method available at the Assessment Center website (http://assessmentcenter.net). A score of 50 points represents the population average for each scale, and 10 points represent one standard deviation. Higher scores mean more of the specific scale's construct, which may indicate a desirable or an undesirable outcome. The assessment will be done at recruitment (10-13 weeks of gestation) and at week 16 and week 22 of gestation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in PROMIS Emotional Distress - Anxiety - Short Form 8a Score</measure>
    <time_frame>At weeks of gestation 10-13, 16 and 22</time_frame>
    <description>The PROMIS-Anxiety short form assesses anxiety with 8 questions. The form includes 8 items and uses a scale of 1-5 (1=Never, 2=Almost never, 3= Sometimes, 4=Often, 5=Almost always). The raw score is the sum of the points for each response. A higher than average raw score indicates higher than average anxiety. A higher score represents higher levels of anxiety. The assessment will be done at recruitment (10-13 weeks of gestation) and at week 16 and week 22 of gestation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient-Reported Experience Measure (PREM) - Score</measure>
    <time_frame>At 22 weeks of gestation</time_frame>
    <description>A 17-questions validated PREM questionnaire on pregnancy experience that measures three dimensions - type of prenatal care received and test results (seven questions), pregnancy visits (four questions (scales 1-5) and prenatal screening experience (six questions).&#xD;
A profile score by looking at frequencies of responses for each item will be used.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>gestational age at termination of pregnancy</measure>
    <time_frame>Up to 24 weeks of gestational age</time_frame>
    <description>Gestational age at termination of pregnancy for participants having volountary termination</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>percentage of women undergoing invasive diagnostic testing</measure>
    <time_frame>Up to 24 weeks of gestational age</time_frame>
    <description>see outcome title</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">7849</enrollment>
  <condition>Prenatal Disorder</condition>
  <condition>Aneuploidy</condition>
  <arm_group>
    <arm_group_label>Standard of care (2nd tier NIPS)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>For the standard-of-care arm (2nd tier NIPS) women will undergo Traditional integrated prenatal screening i.e. traditional biochemical (+/- NT) and those with a positive screen for T21 or T18 will be offered Second-tier Non-invasive prenatal screening (NIPS) (for T21, T18, T13) or Invasive prenatal testing for fetal aneuploidy. Ultrasound examination in first and second trimester will be done based on clinical care practice ordered by health care provider. Pregnant women with a positive NIPS test will be offered Invasive prenatal testing for fetal aneuploidy (fetal chromosome analysis).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>First-tier NIPS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>For the intervention arm (1st tier NIPS) women will receive First-tier Non-invasive prenatal screening (NIPS) i.e. provide a blood sample between 10-13+5 weeks gestation with NIPS results within 7 - 10 days of sample collection. Ultrasound examination in first and second trimester will be done based on clinical care practice ordered by health care provider. In case of a failed NIPS test (expected to be between 2% and 4% of samples), a new blood sample will be drawn for NIPS retest as well as for a traditional SIPS(serum integrated prenatal screening) or QUAD(quadruple marker prenatal screening) screen (depending on gestational age). Pregnant women with a positive NIPS test will be offered Invasive prenatal testing for fetal aneuploidy (fetal chromosome analysis).</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Traditional integrated prenatal screening</intervention_name>
    <description>biochemical prenatal screening with or without nuchal translucency by US</description>
    <arm_group_label>Standard of care (2nd tier NIPS)</arm_group_label>
    <other_name>IPS</other_name>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Second-tier Non-invasive prenatal screening (NIPS)</intervention_name>
    <description>genomics based NIPS after a positive traditional prenatal screen</description>
    <arm_group_label>Standard of care (2nd tier NIPS)</arm_group_label>
    <other_name>second tier non-invasive prenatal testing (NIPT)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>First-tier Non-invasive prenatal screening (NIPS)</intervention_name>
    <description>genomics based NIPS at first trimester</description>
    <arm_group_label>First-tier NIPS</arm_group_label>
    <other_name>first tier NIPT, Universal NIPS, Universal NIPT</other_name>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Invasive prenatal testing for fetal aneuploidy</intervention_name>
    <description>amniocentesis or chorionic villi sampling (CVS)</description>
    <arm_group_label>First-tier NIPS</arm_group_label>
    <arm_group_label>Standard of care (2nd tier NIPS)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pregnant women 19 years or older wanting prenatal screening&#xD;
&#xD;
          -  10-13+6 wks determined by dating ultrasound or last menstrual period.&#xD;
&#xD;
          -  Not intending to pursue self pay NIPT&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known fetal anomaly at the time of recruitment&#xD;
&#xD;
          -  Multiple gestation&#xD;
&#xD;
          -  Known twin demise&#xD;
&#xD;
          -  Planned CVS or amnio for known genetic condition.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sylvie Langlois, MD FRCPC</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of British Columbia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Francois Rousseau, MD MSc FRCPC</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU de Québec - Université Laval</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kelowna Regional Fertility Center</name>
      <address>
        <city>Kelowna</city>
        <state>British Columbia</state>
        <zip>V1Y 1P2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Prince Rupert Regional Hospital</name>
      <address>
        <city>Prince Rupert</city>
        <state>British Columbia</state>
        <zip>V8J 2A6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's &amp; Women's Health Centre</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V6H 3N1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Ste-Justine</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H3T 1C5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Québec - Université Laval</name>
      <address>
        <city>Québec City</city>
        <state>Quebec</state>
        <zip>G1L3L5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CIUSSS Côte-Nord</name>
      <address>
        <city>Sept-Îles</city>
        <state>Quebec</state>
        <zip>G4R 0N9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>Badeau M, Lindsay C, Blais J, Nshimyumukiza L, Takwoingi Y, Langlois S, Legare F, Giguere Y, Turgeon AF, Witteman W, Rousseau F. Genomics-based non-invasive prenatal testing for detection of fetal chromosomal aneuploidy in pregnant women. Cochrane Database Syst Rev. 2017 Nov 10;11(11):CD011767. doi: 10.1002/14651858.CD011767.pub2.</citation>
    <PMID>29125628</PMID>
  </reference>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>January 21, 2019</study_first_submitted>
  <study_first_submitted_qc>February 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 5, 2019</study_first_posted>
  <last_update_submitted>April 3, 2023</last_update_submitted>
  <last_update_submitted_qc>April 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 4, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>CHU de Quebec-Universite Laval</investigator_affiliation>
    <investigator_full_name>François Rousseau</investigator_full_name>
    <investigator_title>Professor-doctor</investigator_title>
  </responsible_party>
  <keyword>Real life comparative effectiveness</keyword>
  <keyword>Non-invasive prenatal screening</keyword>
  <keyword>Fetal aneuploidy</keyword>
  <keyword>Randomized controlled trial</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aneuploidy</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/NCT03831256
org study id: SIRUL 118984
nct id: NCT03831256
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This project aims to provide high- quality evidence to inform decisions by health care
      organisations about using first-tier non-invasive prenatal screening (NIPS) to replace
      traditional screening tests for trisomy 21, and potentially to screen for other fetal
      chromosome anomalies. We will compare the current screening approach of second-tier NIPS with
      the use of first-tier NIPS in a large cohort of pregnant women.
There is some data on the performance of NIPS as a first tier screening test but our
      systematic review has shown that no trial comparing the effectiveness (utility) of 2nd-tier
      NIPS with that of first-tier NIPS has been published . Further it is important for health
      care decision makers to have evidence produced in Canada since the geographical context of
      healthcare can affect uptake as well as patient decision and thus their healthcare
      trajectories. There is a need for a trial that is between an explanatory trial and a
      pragmatic trial to provide the types of answer that we aim to document in the present state
      of knowledge on NIPS-based screening strategies in Canada. Our Objective is to perform a
      pan-Canadian large-scale comparative utility (clinical outcomes) study of first-tier NIPS
      (expanded or not) as compared to the new standard of care (NIPS as a 2nd tier test performed
      much later during pregnancy and only in high risk pregnancies).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Open-label prospective comparative-effectiveness (utility) randomised trial between first-tier NIPS and the standard of care (2nd-tier NIPS).
primary purpose: Screening
masking: None (Open Label)
measure: Gestational age at diagnosis
time frame: Up to 24 weeks of gestational age
description: gestational age at final result in the sub-set of participants that have received a positive NIPS result and that have been offered diagnostic testing
measure: Gestational age at negative screening result
time frame: Up to 24 weeks of gestational age
description: gestational age at final result in the sub-set of participants that have received a negative screening result
measure: Gestational age at positive screening result
time frame: Up to 24 weeks of gestational age
description: gestational age at final result in the sub-set of participants that have received a positive screening result
measure: proportion of women with no results
time frame: Up to 24 weeks of gestational age
description: proportion of women with no NIPS result at first and second attempt
measure: numbers of days for women with false positive result of screen to wait for result of definite test
time frame: Up to 24 weeks of gestational age
description: Difference between gestational age (in days) at first positive prenatal screening result and final negative screening result
measure: Change in PROMIS-29 Score
time frame: At weeks of gestation 10-13, week 16 and week 22
description: The PROMIS-29 assesses seven health domains: physical function, anxiety, depression, fatigue, sleep disturbance, pain interference, and ability to participate in social roles and activities. Each of the seven domains has four questions which are scored on a five-point Likert scale. The PROMIS-29 scales will be scored using a T-score metric method available at the Assessment Center website (http://assessmentcenter.net). A score of 50 points represents the population average for each scale, and 10 points represent one standard deviation. Higher scores mean more of the specific scale's construct, which may indicate a desirable or an undesirable outcome. The assessment will be done at recruitment (10-13 weeks of gestation) and at week 16 and week 22 of gestation.
measure: Change in PROMIS Emotional Distress - Anxiety - Short Form 8a Score
time frame: At weeks of gestation 10-13, 16 and 22
description: The PROMIS-Anxiety short form assesses anxiety with 8 questions. The form includes 8 items and uses a scale of 1-5 (1=Never, 2=Almost never, 3= Sometimes, 4=Often, 5=Almost always). The raw score is the sum of the points for each response. A higher than average raw score indicates higher than average anxiety. A higher score represents higher levels of anxiety. The assessment will be done at recruitment (10-13 weeks of gestation) and at week 16 and week 22 of gestation.
measure: Patient-Reported Experience Measure (PREM) - Score
time frame: At 22 weeks of gestation
description: A 17-questions validated PREM questionnaire on pregnancy experience that measures three dimensions - type of prenatal care received and test results (seven questions), pregnancy visits (four questions (scales 1-5) and prenatal screening experience (six questions).
A profile score by looking at frequencies of responses for each item will be used.
measure: gestational age at termination of pregnancy
time frame: Up to 24 weeks of gestational age
description: Gestational age at termination of pregnancy for participants having volountary termination
measure: percentage of women undergoing invasive diagnostic testing
time frame: Up to 24 weeks of gestational age
description: see outcome title
arm group label: Standard of care (2nd tier NIPS)
arm group type: Active Comparator
description: For the standard-of-care arm (2nd tier NIPS) women will undergo Traditional integrated prenatal screening i.e. traditional biochemical (+/- NT) and those with a positive screen for T21 or T18 will be offered Second-tier Non-invasive prenatal screening (NIPS) (for T21, T18, T13) or Invasive prenatal testing for fetal aneuploidy. Ultrasound examination in first and second trimester will be done based on clinical care practice ordered by health care provider. Pregnant women with a positive NIPS test will be offered Invasive prenatal testing for fetal aneuploidy (fetal chromosome analysis).
arm group label: First-tier NIPS
arm group type: Experimental
description: For the intervention arm (1st tier NIPS) women will receive First-tier Non-invasive prenatal screening (NIPS) i.e. provide a blood sample between 10-13+5 weeks gestation with NIPS results within 7 - 10 days of sample collection. Ultrasound examination in first and second trimester will be done based on clinical care practice ordered by health care provider. In case of a failed NIPS test (expected to be between 2% and 4% of samples), a new blood sample will be drawn for NIPS retest as well as for a traditional SIPS(serum integrated prenatal screening) or QUAD(quadruple marker prenatal screening) screen (depending on gestational age). Pregnant women with a positive NIPS test will be offered Invasive prenatal testing for fetal aneuploidy (fetal chromosome analysis).
intervention type: Diagnostic Test
intervention name: Traditional integrated prenatal screening
description: biochemical prenatal screening with or without nuchal translucency by US
arm group label: Standard of care (2nd tier NIPS)
other name: IPS
intervention type: Diagnostic Test
intervention name: Second-tier Non-invasive prenatal screening (NIPS)
description: genomics based NIPS after a positive traditional prenatal screen
arm group label: Standard of care (2nd tier NIPS)
other name: second tier non-invasive prenatal testing (NIPT)
intervention type: Diagnostic Test
intervention name: First-tier Non-invasive prenatal screening (NIPS)
description: genomics based NIPS at first trimester
arm group label: First-tier NIPS
other name: first tier NIPT, Universal NIPS, Universal NIPT
intervention type: Diagnostic Test
intervention name: Invasive prenatal testing for fetal aneuploidy
description: amniocentesis or chorionic villi sampling (CVS)
arm group label: First-tier NIPS
arm group label: Standard of care (2nd tier NIPS)
criteria: 
gender: Female
minimum age: 19 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Sylvie Langlois, MD FRCPC
role: Principal Investigator
affiliation: University of British Columbia
last name: Francois Rousseau, MD MSc FRCPC
role: Principal Investigator
affiliation: CHU de Québec - Université Laval
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Canada
citation: Badeau M, Lindsay C, Blais J, Nshimyumukiza L, Takwoingi Y, Langlois S, Legare F, Giguere Y, Turgeon AF, Witteman W, Rousseau F. Genomics-based non-invasive prenatal testing for detection of fetal chromosomal aneuploidy in pregnant women. Cochrane Database Syst Rev. 2017 Nov 10;11(11):CD011767. doi: 10.1002/14651858.CD011767.pub2.
PMID: 29125628
responsible party type: Principal Investigator
investigator affiliation: CHU de Quebec-Universite Laval
investigator full name: François Rousseau
investigator title: Professor-doctor
mesh term: Aneuploidy
sharing ipd: No