Ignite Creation Date:
2025-12-24 @ 3:38 PM
Ignite Modification Date:
2025-12-28 @ 11:42 AM
Study NCT ID:
NCT04437992
Status:
UNKNOWN
Last Update Posted:
2020-07-24
First Post:
2020-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility Study of a New Screening Program for Major Aneuploidies (T21, T18, T13) in the Emilia-Romagna Region (SAPERER)
Sponsor:
Azienda Usl di Bologna
Organization:
Study Overview
Official Title:
Feasibility Study of a New Screening Program for Major Aneuploidies (T21, T18, T13) in the Emilia-Romagna Region (SAPERER)
Status:
UNKNOWN
Status Verified Date:
2020-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SAPERER
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: