NCT01052688
Completed
Not Applicable
Noninvasive Screening for Fetal Chromosomal Aneuploidy and Abnormality: Assay Development & Optimization in Affected Pregnancies
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Down Syndrome
- Sponsor
- Sequenom, Inc.
- Enrollment
- 150
- Locations
- 10
- Primary Endpoint
- NIPD result compared to standard test results
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
To collect samples for the purpose of developing and optimizing an in vitro noninvasive prenatal diagnostic (NIPD) test. The NIPD test employs circulating cell free (ccff) DNA extracted from whole blood samples collected from women who are pregnant with a fetus previously determined to have a chromosomal abnormality. The NIPD result will be compared to the standard test results obtained from other test methods such as karyotype, FISH, QF-PCR, and/or any commercially available NIPD test.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subject is female
- •Subject is 18 years or older
- •Subject is no less than 8 and no more than 36 weeks gestation
- •Subject provides a signed and dated informed consent
- •Subject agrees to provide one or more 30-50mL blood sample(s) in accordance with the protocol
- •Subject has a current pregnancy in which the fetus is known to have chromosomal aneuploidy (e.g. T13, T18, T21)
Exclusion Criteria
- •Non-singleton pregnancy in which only one fetus is known to have a chromosomal aneuploidy
Outcomes
Primary Outcomes
NIPD result compared to standard test results
Time Frame: baseline
Result of NIPD test will be compared to the standard test results obtained by karyotype, FISH, QF-PCR, and/or commerical NIPD result.
Study Sites (10)
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