Clinical trial NCT00971334: Noninvasive Screening for Fetal Aneuploidy: A New Maternal Plasma Marker
Official title: Noninvasive Screening for Fetal Aneuploidy: A New Maternal Plasma Marker
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy
Aneuploidy
Down Syndrome
Edwards Syndrome
Keywords: Down Syndrome
Aneuploidy
Amniocentesis
CVS
Lead sponsor: Sequenom, Inc.
Sponsor class: INDUSTRY
Collaborators: name: PRA Health Sciences
First posted: 2009-09-03
Enrollment: 2502
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility criteria: 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:

* None

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Mobile
country: United States
facility: University of South Alabama
state: Alabama
city: La Mesa
country: United States
facility: Grossmont Center for Clinical Research
state: California
city: San Diego
country: United States
facility: IGO
state: California
city: San Diego
country: United States
facility: San Diego Perinatal Center
state: California
city: San Diego
country: United States
facility: Women's Healthcare at Frost Street
state: California
city: San Diego
country: United States
facility: Poway Womens Care
state: California
city: Boynton Beach
country: United States
facility: Visions Clinical Research
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Miami
country: United States
facility: South Florida Perinatal Medicine
state: Florida
city: Pembroke Pines
country: United States
facility: Global Ob/Gyn Centers
state: Florida
city: Sunrise
country: United States
facility: Discovery Clinical Research
state: Florida
city: Sunrise
country: United States
facility: Sheridan Clinical Research
state: Florida
city: Honolulu
country: United States
facility: Fetal Diagnostic Institution of the Pacific
state: Hawaii
city: Boise
country: United States
facility: Women's Clinic
state: Idaho
city: Chicago
country: United States
facility: Reproductive Genetics Institute
state: Illinois
city: Grand Rapids
country: United States
facility: Spectrum Health - Maternal Fetal Medicine
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: St Louis
country: United States
facility: St Louis University
state: Missouri
city: Omaha
country: United States
facility: Methodist Hospital
state: Nebraska
city: Camden
country: United States
facility: Cooper University Hospital
state: New Jersey
city: Winston Salem
country: United States
facility: Lyndhurst Gynecologic Associates
state: North Carolina
city: Columbus
country: United States
facility: Complete Healthcare for Women
state: Ohio
city: Eugene
country: United States
facility: Clinical Trials of America
state: Oregon
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Kingsport
country: United States
facility: Kingsport Perinatology
state: Tennessee
city: Nashville
country: United States
facility: Perinatal Research Center
state: Tennessee
city: Nashville
country: United States
facility: Tenessee Maternal Fetal Medicine
state: Tennessee
city: Houston
country: United States
facility: Houston Perinatal Associates
state: Texas
city: Nantes
country: France
facility: Centre Hospitalier Universitaire de Nantes
city: Paris
country: France
facility: Hopital Cochin Port Royal
city: Paris
country: France
facility: Hopital Robert Debre
city: Toulouse
country: France
facility: Hopital Paule de Viguier - CHU Toulouse
city: Tours
country: France
facility: Centre Hospitalier Regional et Universitaire - Hopital Bretonneau
Study officials:
affiliation: Sequenom, Inc.
name: Allan T Bombard, MD
role: STUDY_DIRECTOR
References: