Prenatal Test for Fetal Aneuploidy Detection

Completed

Conditions studied: Aneuploidy, Trisomy 21

In brief

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

Key facts

Study ID

NCT01256606

Run by

Roche Sequencing Solutions

People needed

4000

Starts

2010-08-01

Expected to finish

2011-11-01

Last updated by the study team

2013-01-10

Who can join

Age: 18 and older, up to 60. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• 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, United States
• Atlanta Perinatal Consultants — Atlanta, Georgia, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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