Status:
COMPLETED
Development of Non-invasive Prenatal Screening Test for Microdeletions Based on Fetal DNA Isolated From Maternal Blood
Lead Sponsor:
Natera, Inc.
Conditions:
Trisomy 21
Trisomy 18
Eligibility:
All Genders
18+ years
Brief Summary
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 i...
Detailed Description
The goal of this study is to further develop a non-invasive prenatal blood test that can diagnose genetic disorders in the fetus by looking at fetal DNA (genetic material) found in the mother's bloods...
Eligibility Criteria
Inclusion
- 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
Exclusion
- •Maternal history of bone marrow or organ transplantation
Key Trial Info
Start Date :
November 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2020
Estimated Enrollment :
1059 Patients enrolled
Trial Details
Trial ID
NCT01852708
Start Date
November 1 2012
End Date
October 1 2020
Last Update
December 30 2020
Active Locations (9)
Enter a location and click search to find clinical trials sorted by distance.
1
Natera, Inc.
San Carlos, California, United States, 94070
2
MFM Group of Southern CA
San Gabriel, California, United States, 91776
3
Washington Women's Wellness Center
Washington D.C., District of Columbia, United States, 20010
4
Saint Peter's University Hospital
New Brunswick, New Jersey, United States, 08901