Noninvasive Screening for Fetal Aneuploidy: A New Maternal Plasma Marker

NCT ID: NCT00971334

Last Updated: 2012-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2502 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-08-31

Study Completion Date

2011-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pregnancy Aneuploidy Down Syndrome Edwards Syndrome

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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PRA Health Sciences

INDUSTRY

Sponsor Role collaborator

Sequenom, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Allan T Bombard, MD

Role: STUDY_DIRECTOR

Sequenom, Inc.

Locations

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University of South Alabama

Mobile, Alabama, United States

Site Status

Grossmont Center for Clinical Research

La Mesa, California, United States

Site Status

IGO

San Diego, California, United States

Site Status

San Diego Perinatal Center

San Diego, California, United States

Site Status

Women's Healthcare at Frost Street

San Diego, California, United States

Site Status

Poway Womens Care

San Diego, California, United States

Site Status

Visions Clinical Research

Boynton Beach, Florida, United States

Site Status

University of Miami

Miami, Florida, United States

Site Status

South Florida Perinatal Medicine

Miami, Florida, United States

Site Status

Global Ob/Gyn Centers

Pembroke Pines, Florida, United States

Site Status

Discovery Clinical Research

Sunrise, Florida, United States

Site Status

Sheridan Clinical Research

Sunrise, Florida, United States

Site Status

Fetal Diagnostic Institution of the Pacific

Honolulu, Hawaii, United States

Site Status

Women's Clinic

Boise, Idaho, United States

Site Status

Reproductive Genetics Institute

Chicago, Illinois, United States

Site Status

Spectrum Health - Maternal Fetal Medicine

Grand Rapids, Michigan, United States

Site Status

William Beaumont Hospital

Royal Oak, Michigan, United States

Site Status

Mayo Clinic

Rochester, Minnesota, United States

Site Status

St Louis University

St Louis, Missouri, United States

Site Status

Methodist Hospital

Omaha, Nebraska, United States

Site Status

Cooper University Hospital

Camden, New Jersey, United States

Site Status

Lyndhurst Gynecologic Associates

Winston-Salem, North Carolina, United States

Site Status

Complete Healthcare for Women

Columbus, Ohio, United States

Site Status

Clinical Trials of America

Eugene, Oregon, United States

Site Status

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Site Status

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

Kingsport Perinatology

Kingsport, Tennessee, United States

Site Status

Perinatal Research Center

Nashville, Tennessee, United States

Site Status

Tenessee Maternal Fetal Medicine

Nashville, Tennessee, United States

Site Status

Houston Perinatal Associates

Houston, Texas, United States

Site Status

Centre Hospitalier Universitaire de Nantes

Nantes, , France

Site Status

Hopital Cochin Port Royal

Paris, , France

Site Status

Hopital Robert Debre

Paris, , France

Site Status

Hopital Paule de Viguier - CHU Toulouse

Toulouse, , France

Site Status

Centre Hospitalier Regional et Universitaire - Hopital Bretonneau

Tours, , France

Site Status

Countries

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United States France

Other Identifiers

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SQNM-T21-202

Identifier Type: -

Identifier Source: org_study_id

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