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Development of a Prenatal Test for Fetal Aneuploidy Detection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01451671
Recruitment Status : Completed
First Posted : October 14, 2011
Last Update Posted : April 30, 2020
Sponsor:
Information provided by (Responsible Party):
Cindy Cisneros, Roche Sequencing Solutions

Brief Summary:
This is an observational study to develop and evaluate a blood based prenatal blood test. Pregnant women confirmed to be carrying a fetus with a chromosomal abnormality will be eligible. Subjects will be asked to provide a blood sample and a limited amount of clinical data that will be recorded on a case report form. All samples and clinical data will be stripped of subject identifiers prior to submission to Ariosa.

Condition or disease
Fetal Complications

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Study Type : Observational
Actual Enrollment : 1500 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Prenatal Test for Fetal Aneuploidy Detection
Study Start Date : November 2010
Actual Primary Completion Date : November 2019
Actual Study Completion Date : November 2019



Primary Outcome Measures :
  1. Identification of aneuploidy [ Time Frame: At enrollment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pregnant women carrying a fetus with an abnormal chromosomal condition that has been confirmed by invasive testing.
Criteria

Inclusion Criteria:

  • Subject has singleton pregnancy
  • Subject is confirmed via invasive testing to be carrying a fetus with a chromosomal abnormality
  • Subject is able to provide informed consent
  • Subject is ≥ 18 years of age

Exclusion Criteria:

  • Subject is pregnant with more than one fetus
  • Subject (mother) has a known aneuploidy

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): NCT01451671


Locations
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United States, California
University of California San Diego
San Diego, California, United States, 92037
United States, Kentucky
Norton Healthcare
Louisville, Kentucky, United States, 40202
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Cindy Cisneros
Investigators
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Study Director: Tracy Roberts Ariosa Diagnostics
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Responsible Party: Cindy Cisneros, CRA, Roche Sequencing Solutions
ClinicalTrials.gov Identifier: NCT01451671    
Other Study ID Numbers: TD002
First Posted: October 14, 2011    Key Record Dates
Last Update Posted: April 30, 2020
Last Verified: April 2020
Keywords provided by Cindy Cisneros, Roche Sequencing Solutions:
fetal
aneuploidy
non-invasive
prenatal
cell free DNA
Additional relevant MeSH terms:
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Aneuploidy
Chromosome Aberrations
Pathologic Processes