Non-Invasive Screening for Fetal Aneuploidy

Overview

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.

Full Title of Study: “Non-Invasive Screening for Fetal Aneuploidy: A New Maternal Plasma Marker”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Cross-Sectional
  • Study Primary Completion Date: April 2011

Interventions

  • Other: Maternal blood screening test for fetal aneuploidy
    • One blood draw of 20 to 30 mL

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sequenom, Inc.
  • Collaborator
    • Obstetrix
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Richard Porreco, MD, Principal Investigator, Obstetrix Medical Group of Colorado
    • Thomas J Garite, MD, Study Director, Obstetrix

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