Clinical Evaluation of the SEQureDx T21 Test In High Risk Pregnancies

Completed

• Conditions: Fetal Aneuploidy; Down Syndrome

• Registration Number: NCT01555346
• Lead Sponsor: Sequenom, Inc.

Brief Summary

Whole blood samples will be collected from high-risk pregnant women to validate the clinical performance of the SEQureDx Trisomy 21 Test.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-02-15
• Study Start: 2012-03
• Study First Submitted QC: 2012-03-14
• Study First Posted: 2012-03-15
• Primary Completion: 2014-10
• Study Completion: 2015-12
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-18
• Last Update Posted: 2016-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 3062

Inclusion Criteria

• Pregnant woman 18 years of age or older at 10 - 22 weeks gestation inclusive
• Subject has one or more high risk indicator for fetal chromosome 21 aneuploidy
• Subject provides signed and dated informed consent
• Subject agrees to provide a whole blood sample

Exclusion Criteria

• Fetal demise at the time of the blood draw
• Previous specimen donation under this protocol

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical Assay Performance	Performance of the assay will be based upon a single blood sample collected during the only study visit from a high risk pregnancy prior to the subject undergoing an invasive procedure (amniocentesis or CVS) to confirm fetal karyotype.	Each subject will provide a single blood sample prior to undergoing an amniocentesis/CVS that will be processed to plasma and stored frozen until the end of the study. Frozen plasma samples will then be analyzed using the SEQureDx Trisomy Test and the sensitivity and specificity of the assay will be determined by comparing the plasma test results to the fetal karyotyping results obtained via aminiocentesis or CVS. A subject's participation ends after the results of the fetal karyotype are obtained and recorded.

Secondary Outcome Measures

Name	Time	Method
Subject selection bias assessment	A single blood sample will be collected at a single clinic visit from high risk pregnancies that refuse to undergo an invasive procedure.	All subjects that enter the study are at high risk for fetal aneuploidy. However, sensitivity and specificity of the assay will be based upon those subjects that have a confirmed fetal karyotype obtained by amniocentesis/CVS. Subject selection bias assessment will be done by comparing SEQureDx Trisomy T21 Test results between women who agree to undergo an invasive procedure to obtain fetal karyotype and women who elect not to undergo an invasive procedure.

Trial Locations

Locations (28)

University of South Alabama; 🇺🇸 Mobile, Alabama, United States

Visions Clinical Research Tuscon; 🇺🇸 Tucson, Arizona, United States

Obstetrix Medical Group of California; 🇺🇸 Campbell, California, United States

Long Beach Memorial Medical Center; 🇺🇸 Long Beach, California, United States

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

San Gabriel Valley Perinatal Medical Center; 🇺🇸 Monterey Park, California, United States

Scripps Clinic Carmel Valley; 🇺🇸 San Diego, California, United States

South Florida Perinatal; 🇺🇸 Miami, Florida, United States

Southeast Perinatal Associates - Miramar; 🇺🇸 Miramar, Florida, United States

Southeast Perinatal Associates - Weston; 🇺🇸 Sunrise, Florida, United States

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