Noninvasive Screening for Fetal Aneuploidy: A New Maternal Plasma Marker

Completed

• Conditions: Aneuploidy; Edwards Syndrome; Pregnancy; Down Syndrome

• Registration Number: NCT00971334
• Lead Sponsor: Sequenom, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-09-01
• Study First Submitted QC: 2009-09-02
• Study First Posted: 2009-09-03
• Primary Completion: 2011-09
• Study Completion: 2011-12
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-15
• Last Update Posted: 2012-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 2502

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

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (35)

University of South Alabama; 🇺🇸 Mobile, Alabama, United States

Grossmont Center for Clinical Research; 🇺🇸 La Mesa, 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

Poway Womens Care; 🇺🇸 San Diego, California, United States

Visions Clinical Research; 🇺🇸 Boynton Beach, Florida, United States

University of Miami; 🇺🇸 Miami, Florida, United States

South Florida Perinatal Medicine; 🇺🇸 Miami, Florida, United States

Global Ob/Gyn Centers; 🇺🇸 Pembroke Pines, Florida, United States

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