<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/NCT04437992</url>
  </required_header>
  <id_info>
    <org_study_id>SAPERER</org_study_id>
    <nct_id>NCT04437992</nct_id>
  </id_info>
  <brief_title>Feasibility Study of a New Screening Program for Major Aneuploidies (T21, T18, T13) in the Emilia-Romagna Region (SAPERER)</brief_title>
  <acronym>SAPERER</acronym>
  <official_title>Feasibility Study of a New Screening Program for Major Aneuploidies (T21, T18, T13) in the Emilia-Romagna Region (SAPERER)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Azienda Usl di Bologna</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Azienda Usl di Bologna</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>
      The study is promoted by the Emilia Romagna Region which identified in the Bologna AUSL the&#xD;
      coordinating center (Unità Operativa Complessa Laboratorio Unico Metropolitano, LUM, Maggiore&#xD;
      Hospital). The medical genetics centers, participating in the technical-scientific&#xD;
      coordination group of assessment (resolution No. 1894, 4/11/2019), the family counseling&#xD;
      centers and the region prenatal hospital clinics are involved as collaborative experimental&#xD;
      centers.&#xD;
&#xD;
      Currently, 14,400 combined tests are carried out in the Emilia Romagna Region every year.&#xD;
&#xD;
      As a result offering the new non-invasive NIPT test, it is estimated that the number of&#xD;
      participants in the screening program will increase by up to 20,000/year.&#xD;
&#xD;
      The study will collect data on the women who will access the combined test in the first 9&#xD;
      months of the protocol and join the enrollment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 27, 2020</start_date>
  <completion_date type="Anticipated">April 27, 2021</completion_date>
  <primary_completion_date type="Anticipated">April 27, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>NIPT</measure>
    <time_frame>9 months</time_frame>
    <description>Establish in which percentage invasive tests (amniocentesis and chorionic villus sampling) would be avoidable by replacing routine screening methods (i.e. combined test) with non-invasive prenatal test (NIPT).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of NIPT</measure>
    <time_frame>9 months</time_frame>
    <description>Establish a percentage of NIPT with inconclusive results</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>diagnostic performance</measure>
    <time_frame>9 months</time_frame>
    <description>Verify the diagnostic performance of the Vanadis NIPT method by verification of sensitivity, specificity, and predictive power in comparison to the combined test currently in use</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Detection of Chromosomal Abnormalities</measure>
    <time_frame>9 months</time_frame>
    <description>Evaluate the added value of nuchal translucency for the detection of Chromosomal Abnormalities other than T21, T18, T13</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TAT (turnaround time)</measure>
    <time_frame>9 months</time_frame>
    <description>Evaluate TAT (turnaround time) of the NIPT and operability of the technology adopted by the laboratory</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Validate NIPT organizational infrastructure</measure>
    <time_frame>9 months</time_frame>
    <description>Validate the organizational infrastructure for the NIPT execution in the area outside of the reference laboratory.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">7000</enrollment>
  <condition>Autosomal Aneuploidy</condition>
  <arm_group>
    <arm_group_label>Pregnant women</arm_group_label>
    <description>Pregnant women resident in the Emilia Romagna region who access the combined test at regional counseling centers and hospital prenatal clinics.&#xD;
Women able to understand the information, participate in pre-test counseling and provide informed consent.</description>
  </arm_group>
  <intervention>
    <intervention_type>Genetic</intervention_type>
    <intervention_name>NIPT</intervention_name>
    <description>The test, which requires two 10 ml tubes of blood, will be performed simultaneously with the chemical biomarkers of the combined test at 10-12 weeks of gestation</description>
    <arm_group_label>Pregnant women</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Pregnant women resident in the Emilia Romagna region who access the combined test at&#xD;
        regional counseling centers and hospital prenatal clinics.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pregnant women resident in the Emilia Romagna region who access the combined test at&#xD;
             regional counseling centers and hospital prenatal clinics.&#xD;
&#xD;
          -  Women able to understand the information, participate in pre-test counseling and&#xD;
             provide informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women under the age of 18 and/or unable to give informed consent&#xD;
&#xD;
          -  pregnancies with more than two twins&#xD;
&#xD;
          -  certain evidence of initial twinning, with subsequent disappearance of one of the&#xD;
             twins (vanishing twin)&#xD;
&#xD;
          -  known maternal chromosome mosaicisms present in the mother and involving the&#xD;
             chromosomes subject to investigation&#xD;
&#xD;
          -  presence of neoplasia in pregnant women&#xD;
&#xD;
          -  previous allogeneic transplantation in pregnant women&#xD;
&#xD;
          -  immunotherapy, radiotherapy or hemotransfusion performed in the pregnant woman within&#xD;
             the previous 3 months.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Female</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Regione Emilia Romagna</name>
      <address>
        <city>Bologna</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rita Mancini</last_name>
      <phone>051 6478891</phone>
      <email>rita.mancini@ausl.bologna.it</email>
    </contact>
    <investigator>
      <last_name>Rita Mancini</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 16, 2020</study_first_submitted>
  <study_first_submitted_qc>June 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>July 22, 2020</last_update_submitted>
  <last_update_submitted_qc>July 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>aneuploidies, down syndrome, Edwards syndrome, Patau syndrome</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/NCT04437992
org study id: SAPERER
nct id: NCT04437992
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study is promoted by the Emilia Romagna Region which identified in the Bologna AUSL the
      coordinating center (Unità Operativa Complessa Laboratorio Unico Metropolitano, LUM, Maggiore
      Hospital). The medical genetics centers, participating in the technical-scientific
      coordination group of assessment (resolution No. 1894, 4/11/2019), the family counseling
      centers and the region prenatal hospital clinics are involved as collaborative experimental
      centers.

      Currently, 14,400 combined tests are carried out in the Emilia Romagna Region every year.

      As a result offering the new non-invasive NIPT test, it is estimated that the number of
      participants in the screening program will increase by up to 20,000/year.

      The study will collect data on the women who will access the combined test in the first 9
      months of the protocol and join the enrollment.
observational model: Other
time perspective: Prospective
measure: NIPT
time frame: 9 months
description: Establish in which percentage invasive tests (amniocentesis and chorionic villus sampling) would be avoidable by replacing routine screening methods (i.e. combined test) with non-invasive prenatal test (NIPT).
measure: Percentage of NIPT
time frame: 9 months
description: Establish a percentage of NIPT with inconclusive results
measure: diagnostic performance
time frame: 9 months
description: Verify the diagnostic performance of the Vanadis NIPT method by verification of sensitivity, specificity, and predictive power in comparison to the combined test currently in use
measure: Detection of Chromosomal Abnormalities
time frame: 9 months
description: Evaluate the added value of nuchal translucency for the detection of Chromosomal Abnormalities other than T21, T18, T13
measure: TAT (turnaround time)
time frame: 9 months
description: Evaluate TAT (turnaround time) of the NIPT and operability of the technology adopted by the laboratory
measure: Validate NIPT organizational infrastructure
time frame: 9 months
description: Validate the organizational infrastructure for the NIPT execution in the area outside of the reference laboratory.
arm group label: Pregnant women
description: Pregnant women resident in the Emilia Romagna region who access the combined test at regional counseling centers and hospital prenatal clinics.
Women able to understand the information, participate in pre-test counseling and provide informed consent.
intervention type: Genetic
intervention name: NIPT
description: The test, which requires two 10 ml tubes of blood, will be performed simultaneously with the chemical biomarkers of the combined test at 10-12 weeks of gestation
arm group label: Pregnant women
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
status: Recruiting
contact: 
investigator: 
country: Italy
responsible party type: Sponsor
mesh term: Aneuploidy
sharing ipd: No