Specimen Collection From Pregnant Women at Increased Risk for Fetal Aneuploidy



Status:Recruiting
Conditions:Other Indications
Therapuetic Areas:Other
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:May 2011
End Date:March 2017

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Trial Summary
Trial Overview
Inclusion Criteria

Collection of Whole Blood Specimens From Pregnant Women at Increased Risk of Fetal Chromosomal Aneuploidy for Use in Development of the SEQureDx Trisomy 21 Test in the Detection of the Relative Quantity of Chromosome 21 Circulating Cell-Free DNA Extracted From Maternal Plasma

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.

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
We found this trial at
13
sites
Spectrum Health
Grand Rapids, Michigan 49503
Principal Investigator: Asad Sheikh, MD
Phone: 616-391-5066
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Grand Rapids, MI
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University of Alabama at Birmingham
1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: Joseph Biggio, MD
Phone: 205-934-5509
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Birmingham, AL
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Cedars-Sinai Medical Center
8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Principal Investigator: John Williams, MD
Phone: 310-423-5860
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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Los Angeles, CA
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UCSD
San Diego, California 92103
Principal Investigator: Andrew Hull, MD
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San Diego, CA
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The Cooper Health System
Camden, New Jersey 08103
Principal Investigator: Meena Khandelwal, MD
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Camden, NJ
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Medical University of South Carolina
171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Principal Investigator: Christopher Robinson, MD
Phone: 843-792-0347
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Charleston, SC
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Reproductive Genetics Institute
Chicago, Illinois 60602
Principal Investigator: Norman Ginsberg, MD
Phone: 773-472-4900
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Chicago, IL
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Henry Ford Hospital
2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
Principal Investigator: Jacquelyn Roberson, MD
Phone: 313-916-3190
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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Detroit, MI
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IWK Health Centre
Halifax, Nova Scotia
Principal Investigator: Jo-Ann Brock, MD
Phone: 902 470-7158
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Halifax,
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University of Iowa Health Care
Iowa City, Iowa 52242
Principal Investigator: Kristi Borowski, MD
Phone: 319-356-2913
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Iowa City, IA
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Sharp Rees-Stealy Medical Group, Inc.
San Diego, California 92101
Principal Investigator: Denis Tarakjian, MD
Phone: 619-446-1624
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San Diego, CA
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Women's Health Care Research
San Diego, California 92123
Principal Investigator: Rovena Reagan, MD
Phone: 858-505-8672
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San Diego, CA
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Specialty Obstetrics of San Diego
San Diego, California 92130
Principal Investigator: David Dowling, MD
Phone: 858-794-7700
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San Diego, CA
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