NCT01052688

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 150 (actual)
• Sponsor: Sequenom, Inc. · Industry
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Down Syndrome
• Aneuploidy

Interventions

Type	Name	Description
OTHER	Maternal blood draw of 30 to 50ml	Maternal blood draw of 30 to 50mls during pregnancy. Blood may be drawn up to 5 times during the pregnancy between weeks 8 and 36 gestation.

Timeline

• Start date: 2009-11-01
• Primary completion: 2021-08-31
• Completion: 2021-08-31
• First posted: 2010-01-20
• Last updated: 2021-09-20

Locations

10 sites across 1 country: United States