A Clinical Study to Evaluate the Relative Clinical Specificity Performance of the SEQureDx Trisomy Test in Pregnant Women at Low Risk for Fetal Chromosomal Aneuploidy

Sequenom, Inc.24 sites in 1 country3,333 target enrollmentJuly 2012

ConditionsAneuploidy Down Syndrome Noninvasive Prenatal Screening

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Aneuploidy
Sponsor: Sequenom, Inc.
Enrollment: 3333
Locations: 24
Primary Endpoint: Estimate the false positive rate of SEQureDx Trisomy 21 Test
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Pregnant women with low risk indicators for fetal chromosomal aneuploidy will be enrolled. Study blood will be collected in the first or second trimester at a scheduled prenatal screening visit, processed to plasma, and stored frozen until analysis. Each pregnancy will be followed until delivery and the birth outcome recorded.

Registry

clinicaltrials.gov

Start Date

July 2012

End Date

December 2015

Last Updated

10 years ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

Sequenom, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Pregnancy is 10-22 weeks gestation
•Between 18-34 years of age inclusive at estimated date of delivery
•No prenatal screening indicators for high risk including serum biochemical and ultrasound screening
•No personal or family history of Down syndrome
•Willing to provide written informed consent
•Willing to provide a whole blood sample
•Willing to provide access to medical records supporting fetal outcome