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

NCT03559374 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1200

Last updated 2018-08-29

No results posted yet for this study

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

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)

Sponsors & Collaborators

  • A.O.U. Città della Salute e della Scienza

    collaborator OTHER

  • PerkinElmer, Wallac Oy

    lead INDUSTRY

Principal Investigators

  • Enza Pavanello · Centro Screening neonatale e prenatale del Piemonte e Valle d'Aosta AOU Città della Salute e della Scienza di Torino

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-20
Primary Completion
2020-04-30
Completion
2020-08-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03559374 on ClinicalTrials.gov