Clinical Trial: Non-invasive Prenatal Diagnostic Validation Study
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: Development of Non-invasive Prenatal Diagnostic Test Based on Fetal DNA Isolated From Maternal Blood
Brief Summary: The primary purpose of this study is to collect maternal blood samples from pregnant women to develop a non-invasive prenatal diagnostic test based on fetal DNA isolated from maternal blood.
Detailed Summary:
The investigators will seek to enroll subjects to collect the following types of samples:
- Up to 2,000 maternal blood samples along with their corresponding paternal blood, buccal or saliva samples (1,000 required for final analysis).
- Up to 200 maternal blood samples from carrying a fetus with a confirmed chromosomal abnormality or genetic disorder, along with their corresponding paternal blood, buccal or saliva samples (50 required for final analysis). For women who opted for termination, a genetic sample of the fetus may also be collected.
- Up to 1,000 buccal or saliva samples from paternal grandfathers and/or the biological father's brothers.
- Up to 1,000 cord, buccal or saliva samples from the born children.
- Up to 40 blood samples (20 non-pregnant females and 20 males) from healthy volunteers (20 required for final analysis)
- Up to 400 blood samples from women undergoing D&C procedure following a miscarriage along with corresponding paternal blood (or buccal or saliva samples) (200 required for final analysis).
Sponsor: Natera, Inc.
Current Primary Outcome: Fetal chromosome abnormality from a maternal plasma sample [ Time Frame: From date of initial blood draw until the date of pregnancy end (miscarriage/termination) or time of birth, whichever came first, assessed up to 10 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Natera, Inc.
Dates:
Date Received: April 2, 2012
Date Started: September 2011
Date Completion:
Last Updated: June 28, 2013
Last Verified: June 2013