Non-invasive Chromosomal Examination of Trisomy Study (NEXT)
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.
|Study Design:||Time Perspective: Prospective|
|Official Title:||Non-invasive Chromosomal Examination of Trisomy|
- Difference in sensitivity and specificity of Ariosa Harmony™ Prenatal Test (AUCt) and combined first-trimester screening for detection of T21. [ Time Frame: Enrollment to delivery ] [ Designated as safety issue: No ]
|Study Start Date:||March 2012|
|Estimated Study Completion Date:||January 2014|
|Estimated Primary Completion Date:||November 2013 (Final data collection date for primary outcome measure)|
Patient with a trisomy 21 pregnancy confirmed by genetic testing.
Patients without a trisomy 21 pregnancy confirmed by either genetic testing or a normal newborn phenotype.
Show 36 Study Locations
|Principal Investigator:||Mary E. Norton, MD||Stanford University|
|Principal Investigator:||Ronald Wapner, MD||Columbia University|