Last reviewed · How we verify
NCT04437992: SAPERER
Feasibility Study of a New Screening Program for Major Aneuploidies (T21, T18, T13) in the Emilia-Romagna Region (SAPERER)
trial testing NIPT in Autosomal Aneuploidy in 7,000 participants. Status unknown.
27 April 2021
Quick facts
| Lead sponsor | Azienda Usl di Bologna |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 7,000 |
| Start date | 27 January 2020 |
| Primary completion | 27 April 2021 |
| Estimated completion | 27 April 2021 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- NIPT
Conditions studied
- Autosomal Aneuploidy — all drugs for Autosomal Aneuploidy →
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):
-
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
Verify or expand the search:
- PubMed search for NCT04437992
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04437992 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Azienda Usl di Bologna
- Last refreshed: 24 July 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04437992.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing