NCT04437992

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 7,000 (estimated)
• Sponsor: Azienda Usl di Bologna · Other Government
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Autosomal Aneuploidy

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-01-27
• Primary completion: 2021-04-27
• Completion: 2021-04-27
• First posted: 2020-06-18
• Last updated: 2020-07-24

Locations

1 site across 1 country: Italy