Development of Non-invasive Prenatal Screening Test for Microdeletions Based on Fetal DNA Isolated From Maternal Blood

Completed

Conditions studied: Trisomy 21, Trisomy 18, Trisomy 13, Sex Chromosome Abnormalities, Microdeletion Syndromes

In brief

The purpose of this study is to collect maternal blood samples from pregnant women carrying a fetus with a confirmed diagnosis of chromosomal abnormality or genetic disorder including microdeletions in order to further develop a non-invasive prenatal screening test based on fetal DNA isolated from maternal blood.

Key facts

Study ID

NCT01852708

Run by

Natera, Inc.

People needed

1059

Starts

2012-11-01

Expected to finish

2020-10-01

Last updated by the study team

2020-12-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age 18 or older at enrollment
• Gestation age of at least 9 weeks, 0 days by best obstetrical estimate
• One or more fetuses with a clinically confirmed diagnosis of a genetic variant of interest via karyotype, FISH, chromosomal microarray or other genetic assay AND/OR
• One or more fetuses with any variant of fetal structure that is expected to require medical or surgical intervention in the newborn period, shorten lifespan, affect intellectual development or otherwise indicate a genetic anomaly AND/OR
• Positive high risk noninvasive prenatal screening or serum screening result
• Able to provide informed consent

You may not qualify if…

• Maternal history of bone marrow or organ transplantation

Where it is running

• Natera, Inc. — San Carlos, California, United States
• MFM Group of Southern CA — San Gabriel, California, United States
• Washington Women's Wellness Center — Washington D.C., District of Columbia, United States
• Saint Peter's University Hospital — New Brunswick, New Jersey, United States
• Columbia University — New York, New York, United States
• The Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Dr. Meltzer Clinic — Houston, Texas, United States
• Hospital Materno Infantil Vall d'Hebron — Barcelona, Spain
• GenePhile Biosciences — Taipei, Taiwan

Full record on ClinicalTrials.gov

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