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NCT01256606 Clinical Trial

Prenatal Test for Fetal Aneuploidy Detection

Aneuploidy Clinical Trial

Official title:
Investigational Study of a Prenatal Diagnostic Test for Fetal Aneuploidy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01256606
Other study ID # TT001
Secondary ID
Status Completed
Phase N/A
First received November 22, 2010
Last updated January 8, 2013
Start date August 2010
Est. completion date November 2011

Study information
Verified date January 2013
Source Ariosa Diagnostics, Inc
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 4000
Est. completion date November 2011
Est. primary completion date November 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 60 Years
Eligibility 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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States Atlanta Perinatal Consultants Atlanta Georgia
United States Medical College of Wisconsin Milwaukee Wisconsin
United States East Bay Perinatal Medical Associates Oakland California
United States Prenatal Diagnosis of Northern California Sacramento California
United States University of California - San Diego San Diego California
United States University of California - San Francisco San Francisco California

Sponsors (1)
Lead Sponsor Collaborator
Ariosa Diagnostics, Inc

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Comparison of blood test to results from chorionic villus sampling or amniocentesis for fetal aneuploidy detection 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. 24 months No
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