Non-invasive Chromosomal Examination of Trisomy Study
- Conditions
- Trisomy 21
- Registration Number
- NCT01511458
- Lead Sponsor
- Roche Sequencing Solutions
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 18955
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Difference in sensitivity and specificity of Ariosa Harmony™ Prenatal Test (AUCt) and combined first-trimester screening for detection of T21. Enrollment to delivery
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (36)
Tucson Medical Center
🇺🇸Tucson, Arizona, United States
Christiana Care Health System
🇺🇸Newark, Delaware, United States
Altus Research
🇺🇸Lake Worth, Florida, United States
Leiden University Medical Center
🇳🇱Leiden, Netherlands
Perinatal Diagnostic Center
🇺🇸Riverside, California, United States
East Bay Perinatal Associates
🇺🇸Oakland, California, United States
Stanford University
🇺🇸Palo Alto, California, United States
Northshore University Health System
🇺🇸Evanston, Illinois, United States
Partners in Obstetrics and Gynecology
🇺🇸Pawtucket, Rhode Island, United States
Early Risk Assessment Program - University of Alberta
🇨🇦Calgary, Alberta, Canada
Abington Memorial Hospital
🇺🇸Abington, Pennsylvania, United States
Women's Health Care Group of Pennsylvania
🇺🇸Wynnewood, Pennsylvania, United States
Karolinska University Hospital
🇸🇪Stockholm, Sweden
University Hospitals Leuven
🇧🇪Leuven, Belgium
St. Peters University Medical Center
🇺🇸New Brunswick, New Jersey, United States
Thomas Jefferson Univeristy Hospital
🇺🇸Philadelphia, Pennsylvania, United States
The Institute of Prenatal Diagnosis and Reproductive Medicine
🇺🇸San Gabriel, California, United States
Robert Wood Johnson School of Medicine
🇺🇸New Brunswick, New Jersey, United States
Fetal Diagnostic Institute of the Pacific
🇺🇸Honolulu, Hawaii, United States
Columbia University
🇺🇸New York, New York, United States
Ottawa Hospital and Research Institute
🇨🇦Ottawa, Ontario, Canada
Mount Sinai University
🇨🇦Toronto, Ontario, Canada
Maastricht University Medical Center
🇳🇱Maastricht, Netherlands
University of Perugia
🇮🇹Perugia, Italy
Sahlgrenska University Medical Center
🇸🇪Gothenburg, Sweden
University of Toronto
🇨🇦Toronto, Ontario, Canada
University of California San Diego
🇺🇸San Diego, California, United States
California Pacific Medical Center
🇺🇸San Francisco, California, United States
University of California San Francisco
🇺🇸San Francisco, California, United States
Norton Healthcare
🇺🇸Louisville, Kentucky, United States
Brigham and Women's Hospital - Center for Fetal Medicine and Prenatal Genetics
🇺🇸Boston, Massachusetts, United States
Minnesota Perinatal Associates
🇺🇸Minneapolis, Minnesota, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Northwest Perinatal Center
🇺🇸Portland, Oregon, United States
Oregon Health Sciences University
🇺🇸Portland, Oregon, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States