Non-invasive Chromosomal Examination of Trisomy Study (NEXT)

This study has been completed.
Sponsor:
Collaborator:
Perinatal Quality Foundation: Nuchal Translucency Quality Review
Information provided by (Responsible Party):
Ariosa Diagnostics, Inc
ClinicalTrials.gov Identifier:
NCT01511458
First received: January 13, 2012
Last updated: July 11, 2014
Last verified: July 2014

January 13, 2012
July 11, 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 ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT01511458 on ClinicalTrials.gov 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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Observational
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18955
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.
Female
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Sweden,   Netherlands,   Belgium,   Italy
 
NCT01511458
TD007
Yes
Ariosa Diagnostics, Inc
Ariosa Diagnostics, Inc
Perinatal Quality Foundation: Nuchal Translucency Quality Review
Principal Investigator: Mary E. Norton, MD Stanford University
Principal Investigator: Ronald Wapner, MD Columbia University
Ariosa Diagnostics, Inc
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP