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NCT00770458 Clinical Trial

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

Turner Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00770458
Other study ID # SQNM-Trisomy21-0100
Secondary ID
Status Completed
Phase N/A
First received October 8, 2008
Last updated January 4, 2010
Start date June 2008
Est. completion date December 2009

Study information
Verified date January 2010
Source Sequenom, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 1000
Est. completion date December 2009
Est. primary completion date October 2009
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Exclusion Criteria:

- Subject is not pregnant

- Subject is not willing to provide blood specimen

- Subject is not haveing aneuploid screening

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Locations
Country Name City State
United States Obstetrix Medical Group of Colorado Denver Colorado
United States UCSD Fetal Care & Genetics Center La Jolla California
United States Women & Infants Providence Rhode Island
United States A.R.U.P. Salt Lake City Utah
United States San Diego Perinatal Center San Diego California
United States Obstetrix Medical Group of San Jose San Jose California
United States Obstetrix Medical Group of Washington Seattle Washington

Sponsors (1)
Lead Sponsor Collaborator
Sequenom, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Compare investigational assay results for Down Syndrome to standard of care results. 3 months No
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