Specimen Collection From Pregnant Women at Increased Risk for Fetal Aneuploidy

Sequenom, Inc.2,000 enrolled

Overview

The specimen collection is designed for the purpose of the development of a noninvasive prenatal test for T21.

To collect specimens for the purpose of developing a prenatal aneuploidy test. The test will analyze circulating cell free fetal (ccff) nucleic acid from blood samples from pregnant women who have an increased risk indicator/s for fetal chromosomal aneuploidy and are undergoing invasive prenatal diagnosis by chorionic villus sampling (CVS) and/or genetic amniocentesis. The results of the ccff aneuploidy test will be compared to the chromosomal analysis obtained via CVS or genetic amniocentesis.

Study Type

OBSERVATIONAL

Enrollment

2,000

Conditions

Down Syndrome Fetal Aneuploidy

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * pregnant between 10 and 22 weeks gestation * 18 years of age or older * provides signed and dated informed consent * subject is at increased risk for fetal aneuploidy * subject is willing to undergo a CVS and/or amniocentesis procedure for the purpose of genetic analysis * subject agrees to provide the genetic results of the invasive procedure Exclusion Criteria: * Fetal demise at time of specimen sampling * Previous sample donation under this protocol

Locations (14)

University of Alabama Birmingham

Birmingham, Alabama, United States

RECRUITING

Cedars-Sinai Medical Center

Los Angeles, California, United States

Outcomes

Primary Outcomes

Collect samples and data for assay validation.

Sensitivity and Specificity

Time frame: 9-24 weeks of gestatational age

Data from ClinicalTrials.gov

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