Non-Invasive Chromosomal Evaluation of Trisomy Study



Status:Recruiting
Conditions:Other Indications, Other Indications
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 60
Updated:4/21/2016
Start Date:April 2014
End Date:April 2016
Contact:Romielle Aquino
Email:raquino@ariosadx.com
Phone:408-209-9098

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This study is being conducted to provide clinically annotated samples to support continued
improvements in the Ariosa Test content, methodology, specimen processing and quality
control.


Inclusion Criteria:

- 1. Subject is at least 18 years old and can provide informed consent;

- 2. Subject has a viable singleton or twin pregnancy;

- 3. Subject is confirmed to be at least 10 weeks, 0 days gestation at the time of the
study blood draw;

- 4. Subject is planning to undergo CVS and/or amniocentesis for the purpose of genetic
analysis of the fetus OR the subject has already undergone CVS and/or amniocentesis
and is known to have a fetus with a chromosomal abnormality confirmed by genetic
analysis.

Exclusion Criteria:

- 1. Subject has known aneuploidy;

- 2. Subject is pregnant with more than two fetuses or has had sonographic evidence of
three or more gestational sacs at any time during pregnancy;

- 3. Subject has a fetal demise (including natural or elective reduction) identified
prior to consent;

- 4. Subject has history of malignancy treated with chemotherapy and/or major surgery,
or bone marrow transplant;
We found this trial at
3
sites
Oaks, Pennsylvania 19456
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Oaks, PA
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Chattanooga, Tennessee 37403
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Chattanooga, TN
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San Diego, California 92093
Phone: 760-242-1677
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San Diego, CA
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