Status:

UNKNOWN

Non-Invasive Determination of Fetal Chromosome Abnormalities

Lead Sponsor:

Lenetix Medical Screening Laboratory

Conditions:

Down Syndrome (Trisomy 21)

Edward's Syndrome (Trisomy 18)

Eligibility:

FEMALE

18+ years

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 abno...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

  • The only exclusion criteria are those mentioned.

Key Trial Info

Start Date :

January 1 2009

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

December 1 2009

Estimated Enrollment :

1000 Patients enrolled

Trial Details

Trial ID

NCT00891852

Start Date

January 1 2009

End Date

December 1 2009

Last Update

May 1 2009

Active Locations (7)

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Page 1 of 2 (7 locations)

1

Maryland Perinatal Associates

Rockville, Maryland, United States, 20850

2

Atlantic Maternal Fetal Medicine

Moristown, New Jersey, United States, 07960

3

Winthrop University Hospital

Mineola, New York, United States, 11501

4

Elite Women's Health

New Hyde Park, New York, United States, 11042