Noninvasive Screening for Fetal Aneuploidy: A New Maternal Plasma Marker

Sequenom, Inc.35 sites in 2 countries2,502 target enrollmentAugust 2009

ConditionsPregnancy Aneuploidy Down Syndrome Edwards Syndrome

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Pregnancy
Sponsor: Sequenom, Inc.
Enrollment: 2502
Locations: 35
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 2009

End Date

December 2011

Last Updated

14 years ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

Sequenom, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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