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Non-invasive Chromosomal Examination of Trisomy Study — NEXT  

Trisomy 21 Clinical Trial

Official title:
Non-invasive Chromosomal Examination of Trisomy

Clinical Trial Summary

The purpose of this blinded, multi-center, prospective, case-controlled study is to compare the Ariosa Harmony™ Prenatal Test for trisomy 21 detection with a standard first-trimester prenatal screening test consisting of serum screening (PAPP-A,free beta-hCG [β-hCG] or total hCG) and a nuchal translucency (NT) measurement (i.e. combined first trimester screening) in a general screened population.

The performance characteristics of these two test modalities will be assessed relative to the clinical reference standard of genetic analysis of the fetus or phenotypic characterization and genetic analysis of the newborn.

Clinical Trial Description

n/a

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01511458
Study type Observational
Source Ariosa Diagnostics, Inc
Contact
Status Completed
Phase N/A
Start date March 2012
Completion date May 2014
View Details
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