View Clinical Trial (Medical Research Study)
Noninvasive Screening for Fetal Aneuploidy: A New Maternal Plasma Marker
| City: |
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Grand Rapids |
| State: |
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Michigan |
| Zip Code: |
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49503 |
| Conditions: |
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Pregnancy - Aneuploidy - Down Syndrome - Edwards Syndrome |
| Purpose: |
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The purpose of this study is to collect samples for the purpose of developing a prenatal
aneuploid test using circulating cell free fetal (ccff) nucleic acid from blood samples from
pregnant women who have a high-risk pregnancy undergoing invasive prenatal diagnosis by
chorionic villus sampling (CVS) and/or genetic amniocentesis. The results of the ccff
aneuploid test will be compared to the chromosomal analysis obtained via CVS or
amniocentesis.
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| Study Summary: |
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| Criteria: |
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Inclusion Criteria:
- Subject is female
- Subject is pregnant
- Subject is 18 years of age or older
- Subject provides a signed and dated informed consent
- Subject agrees to provide a 30-50mL blood sample
- Subject is at increased risk for Down syndrome or other aneuploidies (greater than or
equal to 35 years of age at time of delivery, elevated risk by maternal serum markers
including Triple, Quad and integrated test, fetal birth defects or markers identified
by ultrasound or family history of aneuploidy).
- Subject plans to undergo an amniocentesis and/or CVS procedure
- Subject agrees that the FISH, karyotype, and/or QF-PCR results obtained via the
invasive procedure will be provided
Exclusion Criteria:
- None
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| NCT ID: |
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NCT00971334 |
| Primary Contact: |
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Study Director
Allan T Bombard, MD
Sequenom, Inc.
Julie Day
Phone: (215) 444-8501
Email: DayJulie@PRAIntl.com
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| Backup Contact: |
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N/A |
| Location Contact: |
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Grand Rapids, Michigan 49503
United States
Lori Oosterman
Phone: 616-391-3681
Email: lori.oosterman@spectrum-health.org
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 18, 2013 |
| Modifications to this listing: |
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