Status:
COMPLETED
Prenatal Test for Fetal Aneuploidy Detection
Lead Sponsor:
Roche Sequencing Solutions
Conditions:
Aneuploidy
Trisomy 21
Eligibility:
FEMALE
18-60 years
Brief Summary
The purpose of this study is to develop and evaluate a blood test for pregnant women for detection of fetal aneuploidy.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
4000 Patients enrolled
Trial Details
Trial ID
NCT01256606
Start Date
August 1 2010
End Date
November 1 2011
Last Update
January 10 2013
Active Locations (6)
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1
East Bay Perinatal Medical Associates
Oakland, California, United States, 94609
2
Prenatal Diagnosis of Northern California
Sacramento, California, United States, 95815
3
University of California - San Diego
San Diego, California, United States, 92121
4
University of California - San Francisco
San Francisco, California, United States, 94122