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NCT04437992: SAPERER

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

Status unknown Last updated 24 July 2020
What this trial tests

trial testing NIPT in Autosomal Aneuploidy in 7,000 participants. Status unknown.

Timeline
27 January 2020
Primary endpoint
27 April 2021
27 April 2021

Quick facts

Lead sponsorAzienda Usl di Bologna
StatusStatus unknown
Study typeOBSERVATIONAL
Enrollment7,000
Start date27 January 2020
Primary completion27 April 2021
Estimated completion27 April 2021
Sites1 location across Italy

Drugs / interventions tested

Conditions studied

Sponsor

Azienda Usl di Bologna — full company profile →

Who can join

18 and older, female only, with Autosomal Aneuploidy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Screening for major aneuploidies at 10 weeks of gestation in an unselected population: comparing the combined test to the non-invasive prenatal testing with rolling-circle replication (SAPERER study).
    Cerreta V, Musti MA, Simonazzi G, Frazzoni A, et al · · 2026 · PMID 41775005 · DOI 10.1016/j.ejogrb.2026.115035

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