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Non-Invasive Chromosomal Evaluation of Trisomy Study

NCT02201862

CompletedN/A

Sponsor: Cindy Cisneros

Conditions: Aneuploidy, Trisomy 21, Trisomy 18, Trisomy 13, Down Syndrome

Countries: United States

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.

Eligibility overview

Sex: FEMALE

Age: 18 Years to 60 Years

Healthy volunteers: Yes

Study type: OBSERVATIONAL

Eligibility criteria

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;

Locations (3)

San Diego, California, United States
Oaks, Pennsylvania, United States
Chattanooga, Tennessee, United States