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Feasibility Study of a New Screening Program for Major Aneuploidies (T21, T18, T13) in the Emilia-Romagna Region (SAPERER) (SAPERER)

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ClinicalTrials.gov Identifier: NCT04437992
Recruitment Status : Recruiting
First Posted : June 18, 2020
Last Update Posted : July 24, 2020
Sponsor:
Information provided by (Responsible Party):
Azienda Usl di Bologna

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment
Autosomal Aneuploidy Genetic: NIPT

Study Design
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Study Type : Observational
Estimated Enrollment : 7000 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Feasibility Study of a New Screening Program for Major Aneuploidies (T21, T18, T13) in the Emilia-Romagna Region (SAPERER)
Actual Study Start Date : January 27, 2020
Estimated Primary Completion Date : April 27, 2021
Estimated Study Completion Date : April 27, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Pregnant women
  • 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.
 Genetic: NIPT
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


Outcome Measures
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Primary Outcome Measures :
  1. NIPT [ Time Frame: 9 months ]
    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).


Secondary Outcome Measures :
  1. Percentage of NIPT [ Time Frame: 9 months ]
    Establish a percentage of NIPT with inconclusive results

  2. diagnostic performance [ Time Frame: 9 months ]
    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

  3. Detection of Chromosomal Abnormalities [ Time Frame: 9 months ]
    Evaluate the added value of nuchal translucency for the detection of Chromosomal Abnormalities other than T21, T18, T13

  4. TAT (turnaround time) [ Time Frame: 9 months ]
    Evaluate TAT (turnaround time) of the NIPT and operability of the technology adopted by the laboratory

  5. Validate NIPT organizational infrastructure [ Time Frame: 9 months ]
    Validate the organizational infrastructure for the NIPT execution in the area outside of the reference laboratory.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Pregnant women resident in the Emilia Romagna region who access the combined test at regional counseling centers and hospital prenatal clinics.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Women under the age of 18 and/or unable to give informed consent
  • pregnancies with more than two twins
  • certain evidence of initial twinning, with subsequent disappearance of one of the twins (vanishing twin)
  • known maternal chromosome mosaicisms present in the mother and involving the chromosomes subject to investigation
  • presence of neoplasia in pregnant women
  • previous allogeneic transplantation in pregnant women
  • immunotherapy, radiotherapy or hemotransfusion performed in the pregnant woman within the previous 3 months.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04437992


Locations
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Italy
Regione Emilia Romagna Recruiting
Bologna, Italy
Contact: Rita Mancini    051 6478891    rita.mancini@ausl.bologna.it   
Principal Investigator: Rita Mancini         
Sponsors and Collaborators
Azienda Usl di Bologna
More Information
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Responsible Party: Azienda Usl di Bologna
ClinicalTrials.gov Identifier: NCT04437992    
Other Study ID Numbers: SAPERER
First Posted: June 18, 2020    Key Record Dates
Last Update Posted: July 24, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Azienda Usl di Bologna:
aneuploidies, down syndrome, Edwards syndrome, Patau syndrome
Additional relevant MeSH terms:
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Aneuploidy
Chromosome Aberrations
Pathologic Processes