Clinical Evaluation of the SEQureDx T21 Test In High Risk Pregnancies
- Conditions
- Fetal AneuploidyDown Syndrome
- Registration Number
- NCT01555346
- Lead Sponsor
- Sequenom, Inc.
- Brief Summary
Whole blood samples will be collected from high-risk pregnant women to validate the clinical performance of the SEQureDx Trisomy 21 Test.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 3062
- Pregnant woman 18 years of age or older at 10 - 22 weeks gestation inclusive
- Subject has one or more high risk indicator for fetal chromosome 21 aneuploidy
- Subject provides signed and dated informed consent
- Subject agrees to provide a whole blood sample
- Fetal demise at the time of the blood draw
- Previous specimen donation under this protocol
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical Assay Performance Performance of the assay will be based upon a single blood sample collected during the only study visit from a high risk pregnancy prior to the subject undergoing an invasive procedure (amniocentesis or CVS) to confirm fetal karyotype. Each subject will provide a single blood sample prior to undergoing an amniocentesis/CVS that will be processed to plasma and stored frozen until the end of the study. Frozen plasma samples will then be analyzed using the SEQureDx Trisomy Test and the sensitivity and specificity of the assay will be determined by comparing the plasma test results to the fetal karyotyping results obtained via aminiocentesis or CVS. A subject's participation ends after the results of the fetal karyotype are obtained and recorded.
- Secondary Outcome Measures
Name Time Method Subject selection bias assessment A single blood sample will be collected at a single clinic visit from high risk pregnancies that refuse to undergo an invasive procedure. All subjects that enter the study are at high risk for fetal aneuploidy. However, sensitivity and specificity of the assay will be based upon those subjects that have a confirmed fetal karyotype obtained by amniocentesis/CVS. Subject selection bias assessment will be done by comparing SEQureDx Trisomy T21 Test results between women who agree to undergo an invasive procedure to obtain fetal karyotype and women who elect not to undergo an invasive procedure.
Trial Locations
- Locations (28)
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
South Florida Perinatal
🇺🇸Miami, Florida, United States
Obstetrix Medical Group of Washington, Inc.
🇺🇸Seattle, Washington, United States
Long Beach Memorial Medical Center
🇺🇸Long Beach, California, United States
University of Iowa Health Care
🇺🇸Iowa City, Iowa, United States
Hawaii Pacific Health
🇺🇸Honolulu, Hawaii, United States
University of Maryland
🇺🇸Baltimore, Maryland, United States
North York General Hospital
🇨🇦Toronto, Ontario, Canada
Obstetrix Medical Group of California
🇺🇸Campbell, California, United States
Chuq/Chul
🇨🇦Quebec City, Quebec, Canada
Willis-Knighton Physician Network
🇺🇸Shreveport, Louisiana, United States
William Beaumont Hospital
🇺🇸Royal Oak, Michigan, United States
University of South Alabama
🇺🇸Mobile, Alabama, United States
Visions Clinical Research Tuscon
🇺🇸Tucson, Arizona, United States
Scripps Clinic Carmel Valley
🇺🇸San Diego, California, United States
San Gabriel Valley Perinatal Medical Center
🇺🇸Monterey Park, California, United States
Southeast Perinatal Associates - Miramar
🇺🇸Miramar, Florida, United States
Norton Healthcare
🇺🇸Louisville, Kentucky, United States
Southeast Perinatal Associates - Weston
🇺🇸Sunrise, Florida, United States
Virtua Health
🇺🇸Voorhees, New Jersey, United States
Saint Peter's Hospital
🇺🇸New Brunswick, New Jersey, United States
Regional Obstetrical Consultants
🇺🇸Chatanooga, Tennessee, United States
Saint Lukes Hospital of Kansas City
🇺🇸Kansas City, Missouri, United States
Complete Healthcare for Women
🇺🇸Columbus, Ohio, United States
Jersey Shore University Medical Center
🇺🇸Neptune, New Jersey, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
University of Oklahoma Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States