Specimen Collection from Pregnant Women At Increased Risk for Fetal Aneuploidy
Purpose
The specimen collection is designed for the purpose of the development of a noninvasive prenatal test for T21.
Conditions
- Down Syndrome
- Fetal Aneuploidy
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- Female
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Case-Only
- Time Perspective
- Prospective
Recruiting Locations
University of Alabama Birmingham
Birmingham, Alabama 35294
Birmingham, Alabama 35294
Cedars-Sinai Medical Center
Los Angeles, California 90048
Los Angeles, California 90048
Contact:
Deebra Smith, MD
310- 423-5860
Deebra Smith, MD
310- 423-5860
Sharp-Rees Stealy Medical Group
San Diego, California 92101
San Diego, California 92101
Contact:
Mary LaPage
619 446-1624
Mary LaPage
619 446-1624
Women's Health Care Research
San Diego, California 92123
San Diego, California 92123
Specialty Obstetrics of San Diego
San Diego, California 92130
San Diego, California 92130
Reproductive Genetics Institute
Chicago, Illinois 60602
Chicago, Illinois 60602
Contact:
Denise Ginsberg
773 472-4900
Denise Ginsberg
773 472-4900
University of Iowa Health Care
Iowa City, Iowa 52242
Iowa City, Iowa 52242
Henry Ford Hospital
Detroit, Michigan 48202
Detroit, Michigan 48202
Spectrum Health
Grand Rapids, Michigan 49503
Grand Rapids, Michigan 49503
Contact:
Yvonne Edgerly
616 391-5066
Yvonne Edgerly
616 391-5066
Medical University of South Carolina
Charleston, South Carolina 29466
Charleston, South Carolina 29466
More Details
- Status
- Recruiting
- Sponsor
- Sequenom, Inc.
Study Contact
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.