Non-invasive Chromosomal Examination of Trisomy Study (NEXT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01511458
Recruitment Status : Completed
First Posted : January 18, 2012
Last Update Posted : July 14, 2014
Perinatal Quality Foundation: Nuchal Translucency Quality Review
Information provided by (Responsible Party):
Roche Sequencing Solutions

January 13, 2012
January 18, 2012
July 14, 2014
March 2012
November 2013   (Final data collection date for primary outcome measure)
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 ]
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Complete list of historical versions of study NCT01511458 on Archive Site
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Non-invasive Chromosomal Examination of Trisomy Study
Non-invasive Chromosomal Examination of Trisomy

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.

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Time Perspective: Prospective
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Non-Probability Sample
Pregnant women presenting for combined first trimester screening as part of routine prenatal care
Trisomy 21
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  • Case
    Patient with a trisomy 21 pregnancy confirmed by genetic testing.
  • Control
    Patients without a trisomy 21 pregnancy confirmed by either genetic testing or a normal newborn phenotype.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
May 2014
November 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Subject is at least 18 years old and can provide informed consent.
  2. Subject is planning a hospital delivery.
  3. Subject has a singleton pregnancy with a documented gestational age between 10 weeks, 0 days, and 14 weeks, 2 days, inclusive, at the time of the study blood sample collection.
  4. Subject is planning to undergo combined first trimester prenatal screening that includes NT measurement, and when indicated, serum screening with total or free β-hCG and PAPP-A.

Exclusion Criteria:

  1. Subject has known aneuploidy.
  2. Subject has active or history of malignancy requiring major surgery and/or systemic chemotherapy.
  3. Subject has a twin demise at any gestational age. Twin demise includes any reductions, spontaneous or elective, after sonographic identification of a second (or more) gestational sac. Any clinical, sonographic, or other testing that suggests twin demise would serve as an exclusion criterion.
Sexes Eligible for Study: Female
18 Years to 60 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
Belgium,   Canada,   Italy,   Netherlands,   Sweden,   United States
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Roche Sequencing Solutions
Roche Sequencing Solutions
Perinatal Quality Foundation: Nuchal Translucency Quality Review
Principal Investigator: Mary E. Norton, MD Stanford University
Principal Investigator: Ronald Wapner, MD Columbia University
Roche Sequencing Solutions
July 2014