Non-Invasive Screening for Fetal Aneuploidy

NCT ID: NCT00847990

Last Updated: 2011-09-05

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

5000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-03-31

Study Completion Date

2011-08-31

Brief Summary

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The purpose of this study is to determine if a laboratory test developed by the Sequenom Center for Molecular Medicine (SCMM) that uses a new marker found in the mother's blood can better identify pregnancies that have a child with a chromosome abnormality such as Down syndrome (Trisomy 21), Edwards syndrome (Trisomy 18), or other chromosome abnormality.

Detailed Description

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Conditions

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Down Syndrome Edwards Syndrome

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Pregnant women

Pregnant women who are scheduled to undergo an amniocentesis or CVS procedure and will receive the fetal FISH and/or karyotype results from the procedure.

Maternal blood screening test for fetal aneuploidy

Intervention Type OTHER

One blood draw of 20 to 30 mL

Interventions

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Maternal blood screening test for fetal aneuploidy

One blood draw of 20 to 30 mL

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Subject is willing to provide written informed consent
* Pregnant female with singleton gestation 18 years of age or older
* Subject agrees to provide a 20 to 30 mL venous blood sample
* Subject is one of the following: A) currently scheduled to undergo an amniocentesis and/or CVS procedure, OR B) currently in the first trimester of pregnancy and planning to undergo an amniocentesis in the second trimester
* Subject will receive results of a genetic analysis that includes evaluation of the fetus for aneuploidy

Exclusion Criteria

* Subject lacks the capacity to provide informed consent
* Twins, triplets or other multiple gestation
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Obstetrix

UNKNOWN

Sponsor Role collaborator

Sequenom, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Richard Porreco, MD

Role: PRINCIPAL_INVESTIGATOR

Obstetrix Medical Group of Colorado

Thomas J Garite, MD

Role: STUDY_DIRECTOR

Obstetrix

Locations

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Desert Good Samaritan Hospital

Mesa, Arizona, United States

Site Status

Banner Good Samaritan Hospital

Phoenix, Arizona, United States

Site Status

Phoenix Perinatal Associates, Phoenix Arizona Clinic

Phoenix, Arizona, United States

Site Status

Obstetric Perinatal Clinic Tucson (WOMB)

Tucson, Arizona, United States

Site Status

Fetal Diagnostic Center

Laguna Hills, California, United States

Site Status

Long Beach Memorial Medical Center - Magella Medical Group

Long Beach, California, United States

Site Status

Obstetrix Medical Group of California - Hamilton

San Jose, California, United States

Site Status

Obstetrix Medical Group - Colorado at Presbyterian/St. Luke's Center

Denver, Colorado, United States

Site Status

Obstetrix Medical Group Colorado - Antepartum Testing Unit at Rose Medical Center

Denver, Colorado, United States

Site Status

Obstetrix Medical Group Colorada - Perinatal Resource Center at Swedish Medical Center

Englewood, Colorado, United States

Site Status

Obstetrix Medical Group - Colorado at Littleton Adventist Hospital Perinatal Care Center

Littleton, Colorado, United States

Site Status

Obstetrix Medical Group Colorado at Skyridge Medical Center

Lonetree, Colorado, United States

Site Status

Maternal Fetal Specialists - Northside Atlanta Geogia

Atlanta, Georgia, United States

Site Status

Maternal Fetal Specialist of John's Creek

Duluth, Georgia, United States

Site Status

Maternal Fetal Specialists - Gwinnett

Lawrenceville, Georgia, United States

Site Status

Obstetrix Medical Group of Kansas City, Missouri, Saint Luke's Perinatal Center

Kansas City, Missouri, United States

Site Status

Center for Maternal Fetal Medicine - 7 Hills Office

Las Vegas, Nevada, United States

Site Status

Center for Maternal Fetal Medicine - Pinto Office

Las Vegas, Nevada, United States

Site Status

Center for Maternal Fetal Medicine - Post Road Office

Las Vegas, Nevada, United States

Site Status

Regional Obstetrical Consultants, Chattanooga Tennessee

Chattanooga, Tennessee, United States

Site Status

Regional Obstetrical Consultants, Knoxville Tennessee

Knoxville, Tennessee, United States

Site Status

Texas Prenatal Group of San Antonio

San Antonio, Texas, United States

Site Status

Obstetrix Medical Group of Washington, Eastside Maternal Fetal Medicine

Bellevue, Washington, United States

Site Status

Obstetrix Medical Group of Washington, MFM Clinic at Evergreen Medical Center

Kirkland, Washington, United States

Site Status

Obstetrix Medical Group of Washington, Inc

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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SQNM-T21-301

Identifier Type: -

Identifier Source: org_study_id

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