Non-invasive Prenatal Diagnostic Validation Study
| Status: | Completed |
|---|---|
| Conditions: | Other Indications |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/27/2013 |
| Start Date: | September 2011 |
| End Date: | December 2012 |
| Contact: | Sallie McAdoo, MS |
| Email: | smcadoo@natera.com |
| Phone: | 650-249-9090 |
Development of Non-invasive Prenatal Diagnostic Test Based on Fetal DNA Isolated From Maternal Blood
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.
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).
Inclusion Criteria:
- Pregnant women who volunteer to donate blood sample during the first -, second-
and/or third trimester
- The biological father of the child (or the father's brother and/or father) has to be
at least 18 years of age and consent to his blood, buccal, or saliva collection.
- Pregnant women whose fetus was diagnosed with a chromosomal abnormality or genetic
disorder by either amniocentesis or chorionic villus sampling who volunteer to
donate a blood sample.
- Pregnant women who volunteer to donate a blood sample after their spontaneous
miscarriage prior to undergoing D&C procedure and who choose to utilize Natera's
commercial products of conception molecular karyotyping service.
- Healthy volunteers (non-pregnant female and male) who volunteer to donate their blood
sample.
- Umbilical cord blood or cheek swab/saliva samples from born children o Pregnant women
who have participated in donating a blood sample during their pregnancy have the
option to donate either an umbilical cord blood sample after child delivery, or a
cheek swab or saliva sample from the born child using Natera's home kit.
Exclusion Criteria:
- Women carrying multiples
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