Clinical Evaluation of the SEQureDx T21 Test In High Risk Pregnancies

Completed

Conditions studied: Down Syndrome, Fetal Aneuploidy

In brief

Whole blood samples will be collected from high-risk pregnant women to validate the clinical performance of the SEQureDx Trisomy 21 Test.

Key facts

Study ID

NCT01555346

Run by

Sequenom, Inc.

People needed

3062

Starts

2012-03-01

Expected to finish

2015-12-01

Last updated by the study team

2016-04-20

Who can join

Age: 18 and older, up to 60. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Fetal demise at the time of the blood draw
• Previous specimen donation under this protocol

Where it is running

• University of South Alabama — Mobile, Alabama, United States
• Visions Clinical Research Tuscon — Tucson, Arizona, United States
• Obstetrix Medical Group of California — Campbell, California, United States
• Long Beach Memorial Medical Center — Long Beach, California, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• San Gabriel Valley Perinatal Medical Center — Monterey Park, California, United States
• Scripps Clinic Carmel Valley — San Diego, California, United States
• South Florida Perinatal — Miami, Florida, United States
• Southeast Perinatal Associates - Miramar — Miramar, Florida, United States
• Southeast Perinatal Associates - Weston — Sunrise, Florida, United States
• Hawaii Pacific Health — Honolulu, Hawaii, United States
• University of Iowa Health Care — Iowa City, Iowa, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• Norton Healthcare — Louisville, Kentucky, United States
• Willis-Knighton Physician Network — Shreveport, Louisiana, United States
• University of Maryland — Baltimore, Maryland, United States
• William Beaumont Hospital — Royal Oak, Michigan, United States
• Saint Lukes Hospital of Kansas City — Kansas City, Missouri, United States
• Jersey Shore University Medical Center — Neptune City, New Jersey, United States
• Saint Peter's Hospital — New Brunswick, New Jersey, United States
• Virtua Health — Sewell, New Jersey, United States
• Virtua Health — Voorhees Township, New Jersey, United States
• University of Cincinnati — Cincinnati, Ohio, United States
• Complete Healthcare for Women — Columbus, Ohio, United States
• University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States

Full record on ClinicalTrials.gov

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