Down Syndrome Clinical Trial
— NICHEOfficial title:
Non-Invasive Chromosomal Evaluation of Trisomy Study
NCT number | NCT02201862 |
Other study ID # | AD201 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | April 2014 |
Est. completion date | August 1, 2019 |
Verified date | April 2020 |
Source | Roche Sequencing Solutions |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 2000 |
Est. completion date | August 1, 2019 |
Est. primary completion date | August 1, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 60 Years |
Eligibility |
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; |
Country | Name | City | State |
---|---|---|---|
United States | Regional Obestrical Consultants | Chattanooga | Tennessee |
United States | Women's Healthcare Group of PA | Oaks | Pennsylvania |
United States | University California San Diego | San Diego | California |
Lead Sponsor | Collaborator |
---|---|
Cindy Cisneros |
United States,
Norton ME, Brar H, Weiss J, Karimi A, Laurent LC, Caughey AB, Rodriguez MH, Williams J 3rd, Mitchell ME, Adair CD, Lee H, Jacobsson B, Tomlinson MW, Oepkes D, Hollemon D, Sparks AB, Oliphant A, Song K. Non-Invasive Chromosomal Evaluation (NICE) Study: results of a multicenter prospective cohort study for detection of fetal trisomy 21 and trisomy 18. Am J Obstet Gynecol. 2012 Aug;207(2):137.e1-8. doi: 10.1016/j.ajog.2012.05.021. Epub 2012 Jun 1. — View Citation
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---|---|---|---|---|
Primary | Detection of aneuploidy | 24 months |
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