Clinical Trial: Non-invasive Chromosomal Examination of Trisomy Study

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Non-invasive Chromosomal Examination of Trisomy

Brief 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.

Detailed Summary:
Sponsor: Roche Sequencing Solutions

Current Primary Outcome: 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 ]

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Roche Sequencing Solutions

Dates:
Date Received: January 13, 2012
Date Started: March 2012
Date Completion:
Last Updated: July 11, 2014
Last Verified: July 2014