Trials / Completed
CompletedNCT01511458
Non-invasive Chromosomal Examination of Trisomy Study
Non-invasive Chromosomal Examination of Trisomy
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 18,955 (actual)
- Sponsor
- Roche Sequencing Solutions · Industry
- Sex
- Female
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Timeline
- Start date
- 2012-03-01
- Primary completion
- 2013-11-01
- Completion
- 2014-05-01
- First posted
- 2012-01-18
- Last updated
- 2014-07-14
Locations
36 sites across 6 countries: United States, Belgium, Canada, Italy, Netherlands, Sweden
Source: ClinicalTrials.gov record NCT01511458. Inclusion in this directory is not an endorsement.