Noninvasive Screening for Fetal Aneuploidy: A New Maternal Plasma Marker
- Conditions
- AneuploidyEdwards SyndromePregnancyDown Syndrome
- Registration Number
- NCT00971334
- Lead Sponsor
- Sequenom, Inc.
- Brief Summary
The purpose of this study is to collect samples for the purpose of developing a prenatal aneuploid test using circulating cell free fetal (ccff) nucleic acid from blood samples from pregnant women who have a high-risk pregnancy undergoing invasive prenatal diagnosis by chorionic villus sampling (CVS) and/or genetic amniocentesis. The results of the ccff aneuploid test will be compared to the chromosomal analysis obtained via CVS or amniocentesis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 2502
- Subject is female
- Subject is pregnant
- Subject is 18 years of age or older
- Subject provides a signed and dated informed consent
- Subject agrees to provide a 30-50mL blood sample
- Subject is at increased risk for Down syndrome or other aneuploidies (greater than or equal to 35 years of age at time of delivery, elevated risk by maternal serum markers including Triple, Quad and integrated test, fetal birth defects or markers identified by ultrasound or family history of aneuploidy).
- Subject plans to undergo an amniocentesis and/or CVS procedure
- Subject agrees that the FISH, karyotype, and/or QF-PCR results obtained via the invasive procedure will be provided
- None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (35)
University of South Alabama
🇺🇸Mobile, Alabama, United States
University of Miami
🇺🇸Miami, Florida, United States
Reproductive Genetics Institute
🇺🇸Chicago, Illinois, United States
William Beaumont Hospital
🇺🇸Royal Oak, Michigan, United States
San Diego Perinatal Center
🇺🇸San Diego, California, United States
Women's Healthcare at Frost Street
🇺🇸San Diego, California, United States
Poway Womens Care
🇺🇸San Diego, California, United States
IGO
🇺🇸San Diego, California, United States
Methodist Hospital
🇺🇸Omaha, Nebraska, United States
Discovery Clinical Research
🇺🇸Sunrise, Florida, United States
Hopital Robert Debre
🇫🇷Paris, France
Hopital Paule de Viguier - CHU Toulouse
🇫🇷Toulouse, France
Global Ob/Gyn Centers
🇺🇸Pembroke Pines, Florida, United States
Women's Clinic
🇺🇸Boise, Idaho, United States
Spectrum Health - Maternal Fetal Medicine
🇺🇸Grand Rapids, Michigan, United States
Thomas Jefferson University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
St Louis University
🇺🇸St Louis, Missouri, United States
Grossmont Center for Clinical Research
🇺🇸La Mesa, California, United States
Clinical Trials of America
🇺🇸Eugene, Oregon, United States
South Florida Perinatal Medicine
🇺🇸Miami, Florida, United States
Centre Hospitalier Universitaire de Nantes
🇫🇷Nantes, France
Centre Hospitalier Regional et Universitaire - Hopital Bretonneau
🇫🇷Tours, France
Complete Healthcare for Women
🇺🇸Columbus, Ohio, United States
Visions Clinical Research
🇺🇸Boynton Beach, Florida, United States
Sheridan Clinical Research
🇺🇸Sunrise, Florida, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Fetal Diagnostic Institution of the Pacific
🇺🇸Honolulu, Hawaii, United States
Lyndhurst Gynecologic Associates
🇺🇸Winston Salem, North Carolina, United States
Kingsport Perinatology
🇺🇸Kingsport, Tennessee, United States
Perinatal Research Center
🇺🇸Nashville, Tennessee, United States
Houston Perinatal Associates
🇺🇸Houston, Texas, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Tenessee Maternal Fetal Medicine
🇺🇸Nashville, Tennessee, United States
Hopital Cochin Port Royal
🇫🇷Paris, France
Cooper University Hospital
🇺🇸Camden, New Jersey, United States