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Prenatal Test for Fetal Aneuploidy Detection

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Roche Sequencing Solutions
ClinicalTrials.gov Identifier:
NCT01256606
First received: November 22, 2010
Last updated: January 8, 2013
Last verified: January 2013
  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:


Further study details as provided by Roche Sequencing Solutions:

Primary Outcome 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.


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   (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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Roche Sequencing Solutions
Investigators
Study Director: Ken Song, MD Ariosa Diagnostics
  More Information

Additional Information:
Responsible Party: Roche Sequencing Solutions
ClinicalTrials.gov Identifier: NCT01256606     History of Changes
Other Study ID Numbers: TT001
Study First Received: November 22, 2010
Last Updated: January 8, 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

ClinicalTrials.gov processed this record on July 21, 2017