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Prenatal Test for Fetal Aneuploidy Detection

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ariosa Diagnostics, Inc
ClinicalTrials.gov Identifier:
NCT01256606
First received: November 22, 2010
Last updated: January 8, 2013
Last verified: January 2013
History of Changes
  Purpose

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


Condition
Aneuploidy
Trisomy 21

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Investigational Study of a Prenatal Diagnostic Test for Fetal Aneuploidy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ariosa Diagnostics, Inc:

Primary Outcome Measures:
  • Comparison of blood test to results from chorionic villus sampling or amniocentesis for fetal aneuploidy detection [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 4000
Study Start Date: August 2010
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Positive for fetal aneuploidy
Negative for fetal aneuploidy

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Pregnant women planning to undergo chorionic villus sampling or amniocentesis for fetal genetic evaluation

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01256606

Locations
United States, California
East Bay Perinatal Medical Associates
Oakland, California, United States, 94609
Prenatal Diagnosis of Northern California
Sacramento, California, United States, 95815
University of California - San Diego
San Diego, California, United States, 92121
University of California - San Francisco
San Francisco, California, United States, 94122
United States, Georgia
Atlanta Perinatal Consultants
Atlanta, Georgia, United States, 30342
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Ariosa Diagnostics, Inc
Investigators
Study Director: Ken Song, MD Ariosa Diagnostics
  More Information

Additional Information:
Sponsor website  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Ariosa Diagnostics, Inc
ClinicalTrials.gov Identifier: NCT01256606     History of Changes
Other Study ID Numbers: TT001
Study First Received: November 22, 2010
Last Updated: January 8, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Aneuploidy
Down Syndrome
Trisomy
Chromosome Aberrations
Pathologic Processes
Mental Retardation
Neurobehavioral Manifestations
 Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn
Chromosome Duplication

ClinicalTrials.gov processed this record on May 16, 2013