Non-Invasive Chromosomal Evaluation of Trisomy Study

Completed

• Conditions: Trisomy 13; Down Syndrome; Aneuploidy; Trisomy 18; Trisomy 21

• Registration Number: NCT02201862
• Lead Sponsor: Cindy Cisneros

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-07-22
• Study First Submitted QC: 2014-07-24
• Study First Posted: 2014-07-28
• Primary Completion: 2019-08-01
• Study Completion: 2019-08-01
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-28
• Last Update Posted: 2020-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 2000

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Detection of aneuploidy	24 months

Trial Locations

Locations (3)

Women's Healthcare Group of PA; 🇺🇸 Oaks, Pennsylvania, United States

Regional Obestrical Consultants; 🇺🇸 Chattanooga, Tennessee, United States

University California San Diego; 🇺🇸 San Diego, California, United States