Status:
COMPLETED
Noninvasive Screening for Fetal Aneuploidy: A New Maternal Plasma Marker
Lead Sponsor:
Sequenom, Inc.
Collaborating Sponsors:
PRA Health Sciences
Conditions:
Pregnancy
Aneuploidy
Eligibility:
FEMALE
18+ years
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...
Eligibility Criteria
Inclusion
- 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
- None
Key Trial Info
Start Date :
August 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
2502 Patients enrolled
Trial Details
Trial ID
NCT00971334
Start Date
August 1 2009
End Date
December 1 2011
Last Update
February 17 2012
Active Locations (35)
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1
University of South Alabama
Mobile, Alabama, United States, 36604-3302
2
Grossmont Center for Clinical Research
La Mesa, California, United States, 91942
3
IGO
San Diego, California, United States, 92121
4
San Diego Perinatal Center
San Diego, California, United States, 92123