Noninvasive Screening for Fetal Aneuploidy: A New Maternal Plasma Marker
1 other identifier
observational
2,502
2 countries
35
Brief Summary
The purpose of this study is to collect samples for the purpose of developing a prenatal aneuploid test using circulating cell free fetal (ccff) nucleic acid from blood samples from pregnant women who have a high-risk pregnancy undergoing invasive prenatal diagnosis by chorionic villus sampling (CVS) and/or genetic amniocentesis. The results of the ccff aneuploid test will be compared to the chromosomal analysis obtained via CVS or amniocentesis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2009
Typical duration for all trials
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 1, 2009
CompletedFirst Posted
Study publicly available on registry
September 3, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedFebruary 17, 2012
February 1, 2012
2.1 years
September 1, 2009
February 15, 2012
Conditions
Keywords
Eligibility Criteria
Pregnant women who are scheduled to undergo a CVS or amniocentesis procedure and will receive the FISH, karyotype and/or QF-PCR results from the procedure.
You may qualify if:
- Subject is female
- Subject is pregnant
- Subject is 18 years of age or older
- Subject provides a signed and dated informed consent
- Subject agrees to provide a 30-50mL blood sample
- Subject is at increased risk for Down syndrome or other aneuploidies (greater than or equal to 35 years of age at time of delivery, elevated risk by maternal serum markers including Triple, Quad and integrated test, fetal birth defects or markers identified by ultrasound or family history of aneuploidy).
- Subject plans to undergo an amniocentesis and/or CVS procedure
- Subject agrees that the FISH, karyotype, and/or QF-PCR results obtained via the invasive procedure will be provided
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sequenom, Inc.lead
- PRA Health Sciencescollaborator
Study Sites (35)
University of South Alabama
Mobile, Alabama, 36604-3302, United States
Grossmont Center for Clinical Research
La Mesa, California, 91942, United States
IGO
San Diego, California, 92121, United States
San Diego Perinatal Center
San Diego, California, 92123, United States
Women's Healthcare at Frost Street
San Diego, California, 92123, United States
Poway Womens Care
San Diego, California, 92128, United States
Visions Clinical Research
Boynton Beach, Florida, 33472, United States
University of Miami
Miami, Florida, 33136, United States
South Florida Perinatal Medicine
Miami, Florida, 33143, United States
Global Ob/Gyn Centers
Pembroke Pines, Florida, 33323, United States
Discovery Clinical Research
Sunrise, Florida, 33323, United States
Sheridan Clinical Research
Sunrise, Florida, 33323, United States
Fetal Diagnostic Institution of the Pacific
Honolulu, Hawaii, 96814, United States
Women's Clinic
Boise, Idaho, 83712, United States
Reproductive Genetics Institute
Chicago, Illinois, 60602, United States
Spectrum Health - Maternal Fetal Medicine
Grand Rapids, Michigan, 49503, United States
William Beaumont Hospital
Royal Oak, Michigan, 48073, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
St Louis University
St Louis, Missouri, 63117, United States
Methodist Hospital
Omaha, Nebraska, 68022, United States
Cooper University Hospital
Camden, New Jersey, 08103, United States
Lyndhurst Gynecologic Associates
Winston-Salem, North Carolina, 27103, United States
Complete Healthcare for Women
Columbus, Ohio, 43231, United States
Clinical Trials of America
Eugene, Oregon, 97401, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Kingsport Perinatology
Kingsport, Tennessee, 37660, United States
Perinatal Research Center
Nashville, Tennessee, 37203, United States
Tenessee Maternal Fetal Medicine
Nashville, Tennessee, 37203, United States
Houston Perinatal Associates
Houston, Texas, 77054, United States
Centre Hospitalier Universitaire de Nantes
Nantes, 44093, France
Hopital Cochin Port Royal
Paris, 75019, France
Hopital Robert Debre
Paris, 75019, France
Hopital Paule de Viguier - CHU Toulouse
Toulouse, 31026, France
Centre Hospitalier Regional et Universitaire - Hopital Bretonneau
Tours, 37044, France
Biospecimen
Plasma and PBMCs
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Allan T Bombard, MD
Sequenom, Inc.
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 1, 2009
First Posted
September 3, 2009
Study Start
August 1, 2009
Primary Completion
September 1, 2011
Study Completion
December 1, 2011
Last Updated
February 17, 2012
Record last verified: 2012-02