Non-Invasive Chromosomal Evaluation of Trisomy Study

Cindy Cisneros3 sites in 1 country2,000 target enrollmentApril 2014

ConditionsAneuploidy Trisomy 21 Trisomy 18 Trisomy 13 Down Syndrome

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Aneuploidy
Sponsor: Cindy Cisneros
Enrollment: 2000
Locations: 3
Primary Endpoint: Detection of aneuploidy
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 2014

End Date

August 1, 2019

Last Updated

6 years ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

Cindy Cisneros

Responsible Party

Sponsor Investigator

Principal Investigator

Cindy Cisneros

CRA

Roche Sequencing Solutions

Eligibility Criteria

Inclusion Criteria

•Subject is at least 18 years old and can provide informed consent;
•Subject has a viable singleton or twin pregnancy;
•Subject is confirmed to be at least 10 weeks, 0 days gestation at the time of the study blood draw;
•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

•Subject has known aneuploidy;
•Subject is pregnant with more than two fetuses or has had sonographic evidence of three or more gestational sacs at any time during pregnancy;
•Subject has a fetal demise (including natural or elective reduction) identified prior to consent;
•Subject has history of malignancy treated with chemotherapy and/or major surgery, or bone marrow transplant;