NCT03620110

A Study Collecting Blood Samples From Pregnant Women to Aid in the Development of a Noninvasive Prenatal Test

Prospective Collection of Whole Blood Specimens From Pregnant Women at Any Risk of Fetal Chromosomal Anomaly for the Development of a Noninvasive Prenatal Test

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,209 (actual)
• Sponsor: Illumina, Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to collect whole blood samples from women with viable pregnancies of at least 10 weeks gestation (at any risk for fetal chromosomal anomaly) for future testing with an investigational noninvasive prenatal test(s) (NIPTs), and to establish clinical truth compared to a clinical reference standard.

Detailed description

This is a prospective, multi-center specimen collection study; each subject's treatment, management, or medical care will not be determined by the study protocol. Women 18 years of age or older with a viable pregnancy of at least 10 weeks gestation will be enrolled. A whole blood sample will be collected from each subject. Subjects will be followed until data or specimens used to establish the clinical reference standard are collected, and pregnancy outcome and birth information is collected (if applicable). If cytogenetic test results from standard-of-care procedures are not available and pregnancies end in live births, a neonatal buccal swab specimen will be collected. Maternal specimens will be processed to plasma and stored for future testing with an investigational NIPT(s). There will be no investigational NIPT results nor centralized CMA LDT results generated under this protocol. Cytogenetic results from standard-of-care procedures and microarray results will be used to classify the clinical status of subjects according to the clinical reference standard.

Conditions

• Pregnancy

Timeline

• Start date: 2018-05-21
• Primary completion: 2019-12-30
• Completion: 2019-12-30
• First posted: 2018-08-08
• Last updated: 2020-01-14

Locations

8 sites across 1 country: United States