Noninvasive Screening for Affected Pregnancies: Assay Development & Optimization in Affected Pregnancies

Completed

Conditions studied: Down Syndrome, Aneuploidy

In brief

To collect samples for the purpose of developing and optimizing an in vitro noninvasive prenatal diagnostic (NIPD) test. The NIPD test employs circulating cell free (ccff) DNA extracted from whole blood samples collected from women who are pregnant with a fetus previously determined to have a chromosomal abnormality. The NIPD result will be compared to the standard test results obtained from other test methods such as karyotype, FISH, QF-PCR, and/or any commercially available NIPD test.

Key facts

Study ID

NCT01052688

Run by

Sequenom, Inc.

People needed

150

Starts

2009-11-01

Expected to finish

2021-08-31

Last updated by the study team

2021-09-20

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Subject is female
• Subject is 18 years or older
• Subject is no less than 8 and no more than 36 weeks gestation
• Subject provides a signed and dated informed consent
• Subject agrees to provide one or more 30-50mL blood sample(s) in accordance with the protocol
• Subject has a current pregnancy in which the fetus is known to have chromosomal aneuploidy (e.g. T13, T18, T21)

You may not qualify if…

• Non-singleton pregnancy in which only one fetus is known to have a chromosomal aneuploidy

Where it is running

• Perinatal Care Associates — Phoenix, Arizona, United States
• St. Joseph's Hospital and medical Center — Phoenix, Arizona, United States
• Sharp Grossmount — San Diego, 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
• Reiter, Hill, Johnson and Nevin — Washington D.C., District of Columbia, United States
• Fetal Diagnostic Institute of the Pacific — Honolulu, Hawaii, United States
• Spectrum Health — Grand Rapids, Michigan, United States
• Women and Infants Hospital of Rhode Island — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

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