Status:
COMPLETED
Non-Invasive Chromosomal Evaluation of Trisomy Study
Lead Sponsor:
Cindy Cisneros
Conditions:
Aneuploidy
Trisomy 21
Eligibility:
FEMALE
18-60 years
Brief Summary
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 Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
April 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2019
Estimated Enrollment :
2000 Patients enrolled
Trial Details
Trial ID
NCT02201862
Start Date
April 1 2014
End Date
August 1 2019
Last Update
April 30 2020
Active Locations (3)
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1
University California San Diego
San Diego, California, United States
2
Women's Healthcare Group of PA
Oaks, Pennsylvania, United States, 19456
3
Regional Obestrical Consultants
Chattanooga, Tennessee, United States, 37403