Status:
COMPLETED
Non-invasive Chromosomal Examination of Trisomy Study
Lead Sponsor:
Roche Sequencing Solutions
Collaborating Sponsors:
Perinatal Quality Foundation: Nuchal Translucency Quality Review
Conditions:
Trisomy 21
Eligibility:
FEMALE
18-60 years
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 screenin...
Eligibility Criteria
Inclusion
- Subject is at least 18 years old and can provide informed consent.
- Subject is planning a hospital delivery.
- 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.
- 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
- Subject has known aneuploidy.
- Subject has active or history of malignancy requiring major surgery and/or systemic chemotherapy.
- 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.
Key Trial Info
Start Date :
March 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
18955 Patients enrolled
Trial Details
Trial ID
NCT01511458
Start Date
March 1 2012
End Date
May 1 2014
Last Update
July 14 2014
Active Locations (36)
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1
Tucson Medical Center
Tucson, Arizona, United States, 85712
2
East Bay Perinatal Associates
Oakland, California, United States, 94609
3
Stanford University
Palo Alto, California, United States, 94305-5317
4
Perinatal Diagnostic Center
Riverside, California, United States, 92501