NCT01429389

Specimen Collection from Pregnant Women At Increased Risk for Fetal Aneuploidy

Collection of Whole Blood Specimens from Pregnant Women At Increased Risk of Fetal Chromosomal Abnormality for Use in Development of a Noninvasive Prenatal Test in the Detection of the Relative Quantity of Chromosomal Material in Circulating Cell-Free DNA Extracted from Maternal Plasma

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 2,000 (estimated)
• Sponsor: Sequenom, Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The specimen collection is designed for the purpose of the development of a noninvasive prenatal test for T21.

Detailed description

To collect specimens for the purpose of developing a prenatal aneuploidy test. The test will analyze circulating cell free fetal (ccff) nucleic acid from blood samples from pregnant women who have an increased risk indicator/s for fetal chromosomal aneuploidy and are undergoing invasive prenatal diagnosis by chorionic villus sampling (CVS) and/or genetic amniocentesis. The results of the ccff aneuploidy test will be compared to the chromosomal analysis obtained via CVS or genetic amniocentesis.

Conditions

• Down Syndrome
• Fetal Aneuploidy

Timeline

• Start date: 2011-05-01
• Primary completion: 2025-12-01
• Completion: 2026-03-01
• First posted: 2011-09-07
• Last updated: 2024-10-16

Locations

14 sites across 2 countries: United States, Canada