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 ]

Maternal plasma will be drawn at the time at which they present while pregnant as long as they are at least 6 weeks along. Additional samples (for confirmation of chromosome makeup) may also be drawn on that fetus when fetal sampling is possible (termination, miscarriage) or on the child at or shortly after birth.


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