Non-Invasive Screening for Fetal Aneuploidy: A New Maternal Plasma Marker
Completed
- Conditions
- Down Syndrome (Trisomy 21)Edwards Syndrome (Trisomy 18)Patau Syndrome (Trisomy 13)Turner Syndrome
- Registration Number
- NCT00770458
- Lead Sponsor
- Sequenom, Inc.
- Brief Summary
Validate that circulating cell free fetal nucleic acid can be used to identify a direct marker for fetal aneuploidy, particularly fetal Down Syndrome (DS), that is better than surrogate markers.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 1000
Inclusion Criteria
- Subject is female
- Subject is pregnant
- Subject is high risk aneuploid patient undergoing genetic counseling, unltrasound screening, amniocentesis and/or CVS procedure
- Subject is willing to provide blood specimen
Exclusion Criteria
- Subject is not pregnant
- Subject is not willing to provide blood specimen
- Subject is not haveing aneuploid screening
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Compare investigational assay results for Down Syndrome to standard of care results. 3 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (7)
Obstetrix Medical Group of Washington
🇺🇸Seattle, Washington, United States
Obstetrix Medical Group of San Jose
🇺🇸San Jose, California, United States
UCSD Fetal Care & Genetics Center
🇺🇸La Jolla, California, United States
San Diego Perinatal Center
🇺🇸San Diego, California, United States
Women & Infants
🇺🇸Providence, Rhode Island, United States
Obstetrix Medical Group of Colorado
🇺🇸Denver, Colorado, United States
A.R.U.P.
🇺🇸Salt Lake City, Utah, United States