Non-Invasive Screening for Fetal Aneuploidy: A New Maternal Plasma Marker

Sequenom, Inc.7 sites in 1 country1,000 target enrollmentJune 2008

ConditionsDown Syndrome (Trisomy 21)Edwards Syndrome (Trisomy 18)Patau Syndrome (Trisomy 13)Turner Syndrome

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Down Syndrome (Trisomy 21)
Sponsor: Sequenom, Inc.
Enrollment: 1000
Locations: 7
Primary Endpoint: Compare investigational assay results for Down Syndrome to standard of care results.
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 2008

End Date

December 2009

Last Updated

16 years ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

Sequenom, Inc.

Eligibility Criteria

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