xml: <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/NCT05981521</url>
    </required_header>
    <id_info>
      <org_study_id>3321</org_study_id>
      <nct_id>NCT05981521</nct_id>
    </id_info>
    <brief_title>Paternal Age and Fetal Aneuploidy</brief_title>
    <official_title>Exploring the Association Between Paternal Age and Trisomy 21 Screening Results.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Clinique Ovo</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Clinique Ovo</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>
        Trisomy 21, commonly known as down syndrome, is the most common chromosomal abnormality in&#xD;
        humans. Advanced maternal age (AMA) is a well-recognized risk factor for trisomy 21, with the&#xD;
        risk increasing significantly beyond the age of 35. Research on the effects of paternal age&#xD;
        on the prenatal risk of trisomy 21 is lacking, with inconsistent findings in the literature.&#xD;
  &#xD;
        The Harmony® prenatal test is an Non-Invasive Prenatal Testing (NIPT) that screens maternal&#xD;
        blood for chromosomal abnormalities in the Cell-Free Fetal DNA (cfDNA). The harmony® prenatal&#xD;
        test can detect conditions such as trisomy 13, 18, and 21, as well as sex chromosome&#xD;
        abnormalities.&#xD;
  &#xD;
        The Optimo test is a prenatal screening test that screens for trisomies 13, 18 and 21 in the&#xD;
        developing fetus using extended biochemical screening in maternal. The Optimo test has shown&#xD;
        high sensitivity and specificity in detecting trisomy 21.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">July 31, 2023</start_date>
    <completion_date type="Anticipated">July 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</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>Trisomy 21 screening results</measure>
      <time_frame>3 to 5 days</time_frame>
      <description>On the day of the Optimo screening test, a questionnaire concerning clinical data (maternal and paternal age, ethnicity, weight, smoking status, pregnancy history) is completed. Blood test and nuchal transparency are done on that day. Results from serum analysis and nuchal transparency are combined to assess the risk of trisomy 21. Association between paternal age and trisomy 21 screening results will be assessed afterwards</description>
    </primary_outcome>
    <enrollment type="Anticipated">30000</enrollment>
    <condition>Trisomy 21</condition>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Optimo prenatal screening test</intervention_name>
      <description>Prenatal screening test done between weeks 11 and 13 of pregnancy to detect conditions such as trisomy 13, 18 and 21</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Pregnant women who underwent Optimo trisomy 21 screening at clinique ovo between January&#xD;
          2014 to June 2023&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Pregnant women aged 18 years or older (at the time of trisomy 18 and 21 screening) and&#xD;
               who were able to complete the questionnaire in either French or English&#xD;
  &#xD;
            -  Pregnant women who completed the entire trisomy 21 screening process at clinique ovo&#xD;
               were included&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients who did not indicate the male partner/donor's age were excluded&#xD;
  &#xD;
            -  Patients who did not complete or sign the clinical information form&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <gender_description>We are evaluating genetic screening test on pregnant women.</gender_description>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Jacques I Kadoch, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>clinique ovo R&amp;D department</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Clinique Ovo</name>
        <address>
          <city>Montréal</city>
          <state>Quebec</state>
          <zip>H4P 2S4</zip>
          <country>Canada</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Canada</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>August 7, 2023</last_update_submitted>
    <last_update_submitted_qc>August 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </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>
  
  
text: 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/NCT05981521
  org study id: 3321
  nct id: NCT05981521
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Trisomy 21, commonly known as down syndrome, is the most common chromosomal abnormality in
        humans. Advanced maternal age (AMA) is a well-recognized risk factor for trisomy 21, with the
        risk increasing significantly beyond the age of 35. Research on the effects of paternal age
        on the prenatal risk of trisomy 21 is lacking, with inconsistent findings in the literature.
  
        The Harmony® prenatal test is an Non-Invasive Prenatal Testing (NIPT) that screens maternal
        blood for chromosomal abnormalities in the Cell-Free Fetal DNA (cfDNA). The harmony® prenatal
        test can detect conditions such as trisomy 13, 18, and 21, as well as sex chromosome
        abnormalities.
  
        The Optimo test is a prenatal screening test that screens for trisomies 13, 18 and 21 in the
        developing fetus using extended biochemical screening in maternal. The Optimo test has shown
        high sensitivity and specificity in detecting trisomy 21.
  observational model: Cohort
  time perspective: Retrospective
  measure: Trisomy 21 screening results
  time frame: 3 to 5 days
  description: On the day of the Optimo screening test, a questionnaire concerning clinical data (maternal and paternal age, ethnicity, weight, smoking status, pregnancy history) is completed. Blood test and nuchal transparency are done on that day. Results from serum analysis and nuchal transparency are combined to assess the risk of trisomy 21. Association between paternal age and trisomy 21 screening results will be assessed afterwards
  intervention type: Diagnostic Test
  intervention name: Optimo prenatal screening test
  description: Prenatal screening test done between weeks 11 and 13 of pregnancy to detect conditions such as trisomy 13, 18 and 21
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: Female
  gender based: Yes
  gender description: We are evaluating genetic screening test on pregnant women.
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Jacques I Kadoch, MD
  role: Principal Investigator
  affiliation: clinique ovo R&D department
  facility: 
  country: Canada
  responsible party type: Sponsor
  mesh term: Down Syndrome
  mesh term: Trisomy
  sharing ipd: No