Status:

COMPLETED

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

Lead Sponsor:

Sequenom, Inc.

Conditions:

Down Syndrome (Trisomy 21)

Edwards Syndrome (Trisomy 18)

Eligibility:

FEMALE

18+ years

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.

Eligibility Criteria

Inclusion

  • 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

  • Subject is not pregnant
  • Subject is not willing to provide blood specimen
  • Subject is not haveing aneuploid screening

Key Trial Info

Start Date :

June 1 2008

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

December 1 2009

Estimated Enrollment :

1000 Patients enrolled

Trial Details

Trial ID

NCT00770458

Start Date

June 1 2008

End Date

December 1 2009

Last Update

January 6 2010

Active Locations (7)

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Page 1 of 2 (7 locations)

1

UCSD Fetal Care & Genetics Center

La Jolla, California, United States, 92037

2

San Diego Perinatal Center

San Diego, California, United States, 92123

3

Obstetrix Medical Group of San Jose

San Jose, California, United States, 95008

4

Obstetrix Medical Group of Colorado

Denver, Colorado, United States, 80218