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NCT01429389Recruiting

Specimen Collection from Pregnant Women At Increased Risk for Fetal Aneuploidy

Sequenom, Inc.

Start Date

5/1/2011

Completion Date

3/1/2026

Summary

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

Detailed Description

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

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Conditions

Down SyndromeFetal Aneuploidy

Locations

University of Alabama Birmingham

Birmingham, Alabama 35294

United States

Cedars-Sinai Medical Center

Los Angeles, California 90048

United States

Sharp-Rees Stealy Medical Group

San Diego, California 92101

United States

UCSD

San Diego, California 92121

United States

Women's Health Care Research

San Diego, California 92123

United States

Specialty Obstetrics of San Diego

San Diego, California 92130

United States

Reproductive Genetics Institute

Chicago, Illinois 60602

United States

University of Iowa Health Care

Iowa City, Iowa 52242

United States

Henry Ford Hospital

Detroit, Michigan 48202

United States

Spectrum Health

Grand Rapids, Michigan 49503

United States

The Cooper Health System

Camden, New Jersey

United States

Medical University of South Carolina

Charleston, South Carolina 29466

United States

IWK Health Centre

Halifax, Nova Scotia B3K 6R8

Canada

North York General Hospital

Toronto, Ontario

Canada