Feasibility Study of a New Screening Program for Major Aneuploidies (T21 T18 T13) in the Emilia-Romagna Region (SAPERER)
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- STATUS
- Recruiting
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- participants needed
- 7000
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- sponsor
- Azienda Usl di Bologna
Summary
The study is promoted by the Emilia Romagna Region which identified in the Bologna AUSL the coordinating center (Unit 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.
Details
| Condition | Autosomal Aneuploidy |
|---|---|
| Age | 18-100 years |
| Treatment | NIPT |
| Clinical Study Identifier | NCT04437992 |
| Sponsor | Azienda Usl di Bologna |
| Last Modified on | 19 February 2024 |
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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