Noninvasive Screening for Fetal Aneuploidy: A New Maternal Plasma Marker

Pregnancy Clinical Trial

Official title:

Noninvasive Screening for Fetal Aneuploidy: A New Maternal Plasma Marker

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00971334
• Other study ID #: SQNM-T21-202
• Status: Completed
• Phase: N/A
• First received: September 1, 2009
• Last updated: February 15, 2012
• Start date: August 2009
• Est. completion date: December 2011

Study information

• Verified date: February 2012
• Source: Sequenom, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2502
• Est. completion date: December 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Aneuploidy
• Down Syndrome
• Edwards Syndrome
• Pregnancy
• Syndrome

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire de Nantes	Nantes
France	Hopital Cochin Port Royal	Paris
France	Hopital Robert Debre	Paris
France	Hopital Paule de Viguier - CHU Toulouse	Toulouse
France	Centre Hospitalier Regional et Universitaire - Hopital Bretonneau	Tours
United States	Women's Clinic	Boise	Idaho
United States	Visions Clinical Research	Boynton Beach	Florida
United States	Cooper University Hospital	Camden	New Jersey
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Reproductive Genetics Institute	Chicago	Illinois
United States	Complete Healthcare for Women	Columbus	Ohio
United States	Clinical Trials of America	Eugene	Oregon
United States	Spectrum Health - Maternal Fetal Medicine	Grand Rapids	Michigan
United States	Fetal Diagnostic Institution of the Pacific	Honolulu	Hawaii
United States	Houston Perinatal Associates	Houston	Texas
United States	Kingsport Perinatology	Kingsport	Tennessee
United States	Grossmont Center for Clinical Research	La Mesa	California
United States	South Florida Perinatal Medicine	Miami	Florida
United States	University of Miami	Miami	Florida
United States	University of South Alabama	Mobile	Alabama
United States	Perinatal Research Center	Nashville	Tennessee
United States	Tenessee Maternal Fetal Medicine	Nashville	Tennessee
United States	Methodist Hospital	Omaha	Nebraska
United States	Global Ob/Gyn Centers	Pembroke Pines	Florida
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania
United States	Mayo Clinic	Rochester	Minnesota
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	IGO	San Diego	California
United States	Poway Womens Care	San Diego	California
United States	San Diego Perinatal Center	San Diego	California
United States	Women's Healthcare at Frost Street	San Diego	California
United States	St Louis University	St Louis	Missouri
United States	Discovery Clinical Research	Sunrise	Florida
United States	Sheridan Clinical Research	Sunrise	Florida
United States	Lyndhurst Gynecologic Associates	Winston Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Sequenom, Inc.	PRA Health Sciences

Countries where clinical trial is conducted

United States,  France,