Clinical Trial: Noninvasive Screening for Affected Pregnancies: Assay Development & Optimization in Affected Pregnancies

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Noninvasive Screening for Fetal Chromosomal Aneuploidy and Abnormality: Assay Development & Optimization in Affected Pregnancies

Brief Summary: To collect samples for the purpose of developing and optimizing an in vitro noninvasive prenatal diagnostic (NIPD) test. The NIPD test employs circulating cell free (ccff) DNA extracted from whole blood samples collected from women who are pregnant with a fetus previously determined to have a chromosomal abnormality. The NIPD result will be compared to the standard test results obtained from other test methods such as karyotype, FISH, QF-PCR, and/or any commercially available NIPD test.

Detailed Summary:
Sponsor: Sequenom, Inc.

Current Primary Outcome: NIPD result compared to standard test results [ Time Frame: baseline ]

Result of NIPD test will be compared to the standard test results obtained by karyotype, FISH, QF-PCR, and/or commerical NIPD result.


Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Sequenom, Inc.

Dates:
Date Received: January 15, 2010
Date Started: November 2009
Date Completion: June 2017
Last Updated: April 18, 2016
Last Verified: April 2016