Autosomal Aneuploidy Clinical Trial
— SAPEREROfficial title:
Feasibility Study of a New Screening Program for Major Aneuploidies (T21, T18, T13) in the Emilia-Romagna Region (SAPERER)
| NCT number | NCT04437992 |
| Other study ID # | SAPERER |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | January 27, 2020 |
| Est. completion date | April 27, 2021 |
| Verified date | June 2020 |
| Source | Azienda Usl di Bologna |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Recruiting |
| Enrollment | 7000 |
| Est. completion date | April 27, 2021 |
| Est. primary completion date | April 27, 2021 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Italy | Regione Emilia Romagna | Bologna |
| Lead Sponsor | Collaborator |
|---|---|
| Azienda Usl di Bologna |
Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | NIPT | 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). | 9 months | |
| Secondary | Percentage of NIPT | Establish a percentage of NIPT with inconclusive results | 9 months | |
| Secondary | diagnostic performance | 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 | 9 months | |
| Secondary | Detection of Chromosomal Abnormalities | Evaluate the added value of nuchal translucency for the detection of Chromosomal Abnormalities other than T21, T18, T13 | 9 months | |
| Secondary | TAT (turnaround time) | Evaluate TAT (turnaround time) of the NIPT and operability of the technology adopted by the laboratory | 9 months | |
| Secondary | Validate NIPT organizational infrastructure | Validate the organizational infrastructure for the NIPT execution in the area outside of the reference laboratory. | 9 months |