Noninvasive Screening for Fetal Aneuploidy: A New Maternal Plasma Marker

Completed

Conditions studied: Pregnancy, Aneuploidy, Down Syndrome, Edwards Syndrome

In brief

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.

Key facts

Study ID

NCT00971334

Run by

Sequenom, Inc.

People needed

2502

Starts

2009-08-01

Expected to finish

2011-12-01

Last updated by the study team

2012-02-17

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• None

Where it is running

• University of South Alabama — Mobile, Alabama, United States
• Grossmont Center for Clinical Research — La Mesa, California, United States
• IGO — San Diego, California, 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
• Visions Clinical Research — Boynton Beach, Florida, United States
• University of Miami — Miami, Florida, United States
• South Florida Perinatal Medicine — Miami, Florida, United States
• Global Ob/Gyn Centers — Pembroke Pines, Florida, United States
• Discovery Clinical Research — Sunrise, Florida, United States
• Sheridan Clinical Research — Sunrise, Florida, United States
• Fetal Diagnostic Institution of the Pacific — Honolulu, Hawaii, United States
• Women's Clinic — Boise, Idaho, United States
• Reproductive Genetics Institute — Chicago, Illinois, United States
• Spectrum Health - Maternal Fetal Medicine — Grand Rapids, Michigan, United States
• William Beaumont Hospital — Royal Oak, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• St Louis University — St Louis, Missouri, United States
• Methodist Hospital — Omaha, Nebraska, United States
• Cooper University Hospital — Camden, New Jersey, United States
• Lyndhurst Gynecologic Associates — Winston-Salem, North Carolina, United States
• Complete Healthcare for Women — Columbus, Ohio, United States
• Clinical Trials of America — Eugene, Oregon, United States
• Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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