Non-Invasive Chromosomal Evaluation of Trisomy Study

Down Syndrome Clinical Trial

— NICHE  

Official title:

Non-Invasive Chromosomal Evaluation of Trisomy Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02201862
• Other study ID #: AD201
• Status: Completed
• 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
• 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;

Related Conditions & MeSH terms

• Aneuploidy
• Down Syndrome
• Trisomy 13
• Trisomy 18
• Trisomy 21

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