Non-Invasive Screening for Fetal Aneuploidy

Completed

• Conditions: Edwards Syndrome; Down Syndrome

• Registration Number: NCT00847990
• Lead Sponsor: Sequenom, Inc.

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2009-02-18
• Study First Submitted QC: 2009-02-19
• Study First Posted: 2009-02-20
• Study Start: 2009-03
• Primary Completion: 2011-04
• Study Completion: 2011-08
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-01
• Last Update Posted: 2011-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 5000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Validate the prenatal aneuploidy LDT with blood samples from pregnant women who are undergoing invasive prenatal diagnosis	During the 1st and 2nd trimester of pregnancy

Trial Locations

Locations (25)

Desert Good Samaritan Hospital; 🇺🇸 Mesa, Arizona, United States

Banner Good Samaritan Hospital; 🇺🇸 Phoenix, Arizona, United States

Phoenix Perinatal Associates, Phoenix Arizona Clinic; 🇺🇸 Phoenix, Arizona, United States

Obstetric Perinatal Clinic Tucson (WOMB); 🇺🇸 Tucson, Arizona, United States

Fetal Diagnostic Center; 🇺🇸 Laguna Hills, California, United States

Long Beach Memorial Medical Center - Magella Medical Group; 🇺🇸 Long Beach, California, United States

Obstetrix Medical Group of California - Hamilton; 🇺🇸 San Jose, California, United States

Obstetrix Medical Group - Colorado at Presbyterian/St. Luke's Center; 🇺🇸 Denver, Colorado, United States

Obstetrix Medical Group Colorado - Antepartum Testing Unit at Rose Medical Center; 🇺🇸 Denver, Colorado, United States

Obstetrix Medical Group Colorada - Perinatal Resource Center at Swedish Medical Center; 🇺🇸 Englewood, Colorado, United States

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