Non-Invasive Determination of Fetal Chromosome Abnormalities

Lenetix Medical Screening Laboratory7 sites in 1 country1,000 target enrollmentJanuary 2009

ConditionsDown Syndrome (Trisomy 21)Edward's Syndrome (Trisomy 18)Patau Syndrome (Trisomy 13)Klinefelter Syndrome (47, XXY)and Other Chromosome Abnormalities.

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Down Syndrome (Trisomy 21)
Sponsor: Lenetix Medical Screening Laboratory
Enrollment: 1000
Locations: 7
Last Updated: 17 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The overall significance of this study is to develop a laboratory developed test (LDT) to use a new marker in the maternal blood to better identify pregnancies that have a child with a chromosome abnormality such as Down syndrome (trisomy 21), Edward's syndrome (trisomy 18), Patau syndrome (trisomy 13), Klinefelter syndrome, (47, XXY), and other chromosome abnormalities. Accomplishing that task would reduce the need for invasive amniocentesis and CVS procedures.

Registry

clinicaltrials.gov

Start Date

January 2009

End Date

December 2009

Last Updated

17 years ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

Lenetix Medical Screening Laboratory

Eligibility Criteria

Inclusion Criteria

•This study is only applicable to women who are between 8 and 30 weeks' gestation and who have been determined increased risk for fetal aneuploidy. In the interest of expediting and simplifying this study, the investigators want only women who have already decided to undergo second-trimester amniocentesis or CVS.