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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date April 2020
Source Roche Sequencing Solutions
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

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;

Study Design


Related Conditions & MeSH terms


Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Cindy Cisneros

Country where clinical trial is conducted

United States, 

References & Publications (1)

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

Outcome

Type Measure Description Time frame Safety issue
Primary Detection of aneuploidy 24 months
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