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Non-invasive Chromosomal Examination of Trisomy Study

NCT01511458 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 18955

Last updated 2014-07-14

No results posted yet for this study

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

  • Trisomy 21

Sponsors & Collaborators

  • Perinatal Quality Foundation: Nuchal Translucency Quality Review

    collaborator UNKNOWN

  • Roche Sequencing Solutions

    lead INDUSTRY

Principal Investigators

  • Mary E. Norton, MD · Stanford University

  • Ronald Wapner, MD · Columbia University

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2013-11-30
Completion
2014-05-31

Countries

  • United States
  • Belgium
  • Canada
  • Italy
  • Netherlands
  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01511458 on ClinicalTrials.gov