NCT03559374

Study of Vanadis® NIPT for Non-invasive Prenatal Screening of Trisomies (T21, T18 and T13)

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,200 (estimated)
• Sponsor: PerkinElmer, Wallac Oy · Industry
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

This study will assess the feasibility of Vanadis NIPT for screening of T21, T18 and T13. The results obtained from Vanadis NIPT will be compared with the study site's current prenatal screening methods. The primary objectives are: 1) To assess the feasibility of Vanadis NIPT for screening of T21, T18 and T13 in the maternal healthcare setting, 2) To assess preliminary performance of Vanadis NIPT for screening of T21 in comparison to site's routine screening methods i.e. combined and integrated tests, and 3) To evaluate preliminary cost effectiveness of Vanadis NIPT use in different models. The secondary objective is to assess the feasibility of Vanadis NIPT regarding determination of fetal sex.

Conditions

• Trisomy 21
• Trisomy 18
• Trisomy 13

Interventions

Type	Name	Description
OTHER	Vanadis NIPT system	A novel cost effective not NGS (next-generation sequencing) test, based on imaging single DNA molecules for high precision NIPT (non-invasive prenatal testing)

Timeline

• Start date: 2018-06-20
• Primary completion: 2020-04-01
• Completion: 2020-08-01
• First posted: 2018-06-18
• Last updated: 2018-08-29

Locations

1 site across 1 country: Italy