Prenatal Test for Fetal Aneuploidy Detection

Overview

The purpose of this study is to develop and evaluate a blood test for pregnant women for detection of fetal aneuploidy.

Full Title of Study: “Investigational Study of a Prenatal Diagnostic Test for Fetal Aneuploidy”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: November 2011

Arms, Groups and Cohorts

  • Positive for fetal aneuploidy
  • Negative for fetal aneuploidy

Clinical Trial Outcome Measures

Primary Measures

  • Comparison of blood test to results from chorionic villus sampling or amniocentesis for fetal aneuploidy detection
    • Time Frame: 24 months
    • Circulating genomic material from maternal blood will be quantified using biochemical techniques to determine the presence of fetal aneuploidy. The results obtained from analysis of circulating genomic material will be compared to the karyotype results from chorionic villus sampling or amniocentesis.

Participating in This Clinical Trial

Inclusion Criteria

  • Subject is 18yrs or older – Subject has a singleton pregnancy – Subject is planning to undergo chorionic villus sampling (CVS) and/or amniocentesis with current pregnancy – Subject is able to provide consent Exclusion Criteria:

  • Subject is pregnant with more than one fetus – Subject (mother) has known aneuploidy – Subject has active malignancy requiring major surgery or systemic chemotherapy or has a history of metastatic cancer. – Subject has already undergone CVS or amniocentesis during current pregnancy prior to study enrollment.

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Roche Sequencing Solutions
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Ken Song, MD, Study Director, Ariosa Diagnostics

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