Non-invasive Chromosomal Examination of Trisomy Study (NEXT)
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|ClinicalTrials.gov Identifier: NCT01511458|
Recruitment Status : Completed
First Posted : January 18, 2012
Last Update Posted : July 14, 2014
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.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||18955 participants|
|Official Title:||Non-invasive Chromosomal Examination of Trisomy|
|Study Start Date :||March 2012|
|Actual Primary Completion Date :||November 2013|
|Actual Study Completion Date :||May 2014|
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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01511458
|Principal Investigator:||Mary E. Norton, MD||Stanford University|
|Principal Investigator:||Ronald Wapner, MD||Columbia University|