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

Sequenom, Inc.1,000 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,000

Conditions

Down Syndrome (Trisomy 21)Edwards Syndrome (Trisomy 18)Patau Syndrome (Trisomy 13)Turner Syndrome

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (7)

UCSD Fetal Care & Genetics Center

La Jolla, California, 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 Colorado

Denver, Colorado, United States

Outcomes

Primary Outcomes

Compare investigational assay results for Down Syndrome to standard of care results.

Time frame: 3 months

Data from ClinicalTrials.gov

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