Trials / Completed
CompletedNCT01574781
Non-invasive Prenatal Diagnostic Validation Study
Development of Non-invasive Prenatal Diagnostic Test Based on Fetal DNA Isolated From Maternal Blood
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,781 (actual)
- Sponsor
- Natera, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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 description
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).
Conditions
- Chromosome 13 Aneuploidy
- Chromosome 18 Aneuploidy
- Chromosome 21 Aneuploidy
- Sex Chromosome Aberrations
- Other Microdeletions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Blood draw | Blood is drawn at the appropriate time given their cohort inclusion. |
| PROCEDURE | Cheek swab/Saliva Sampling | In lieu of blood draw, male relatives may donate cheek swab or saliva sample. Children born to participating women can donate cheek swab or saliva sample soon after birth. |
Timeline
- Start date
- 2011-09-01
- Primary completion
- 2013-04-01
- Completion
- 2013-04-01
- First posted
- 2012-04-10
- Last updated
- 2013-07-02
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01574781. Inclusion in this directory is not an endorsement.