Non-Invasive Chromosomal Evaluation of Trisomy Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-04-30

Study Completion Date

2019-08-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Aneuploidy Trisomy 21 Trisomy 18 Trisomy 13 Down Syndrome

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Euploid Subjects

Subject's with fetal euploidy confirmed by chromosome analysis

No interventions assigned to this group

Aneuploid Subjects

Subject's with fetal aneuploidy confirmed by chromosome analysis

No interventions assigned to this group

Eligibility Criteria

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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;

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes