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
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 Type :||Observational|
|Estimated Enrollment :||7000 participants|
|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|
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
- 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).
- Percentage of NIPT [ Time Frame: 9 months ]Establish a percentage of NIPT with inconclusive results
- 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
- 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
- TAT (turnaround time) [ Time Frame: 9 months ]Evaluate TAT (turnaround time) of the NIPT and operability of the technology adopted by the laboratory
- Validate NIPT organizational infrastructure [ Time Frame: 9 months ]Validate the organizational infrastructure for the NIPT execution in the area outside of the reference laboratory.
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
|Regione Emilia Romagna||Recruiting|
|Contact: Rita Mancini 051 6478891 firstname.lastname@example.org|
|Principal Investigator: Rita Mancini|