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Prenatal Test for Fetal Aneuploidy Detection

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ClinicalTrials.gov Identifier: NCT01256606
Recruitment Status : Completed
First Posted : December 8, 2010
Last Update Posted : January 10, 2013
Sponsor:
Information provided by (Responsible Party):
Roche Sequencing Solutions

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

Condition or disease
Aneuploidy Trisomy 21

Study Type : Observational
Actual Enrollment : 4000 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Investigational Study of a Prenatal Diagnostic Test for Fetal Aneuploidy
Study Start Date : August 2010
Primary Completion Date : November 2011
Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
Positive for fetal aneuploidy
Negative for fetal aneuploidy



Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Roche Sequencing Solutions
Investigators
Study Director: Ken Song, MD Ariosa Diagnostics

Additional Information:
Responsible Party: Roche Sequencing Solutions
ClinicalTrials.gov Identifier: NCT01256606     History of Changes
Other Study ID Numbers: TT001
First Posted: December 8, 2010    Key Record Dates
Last Update Posted: January 10, 2013
Last Verified: January 2013

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