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Clinical Trials/NCT00971334
NCT00971334CompletedNot Applicable

Noninvasive Screening for Fetal Aneuploidy: A New Maternal Plasma Marker

Sequenom, Inc.35 sites in 2 countries2,502 target enrollmentStarted: August 2009Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
2,502
Locations
35
Study OverviewStudy DesignEligibility CriteriaInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study 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.

Study Design

Study Type
Observational
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

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

Exclusion Criteria

  • Not provided

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (35)

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