Noninvasive Screening for Affected Pregnancies: Assay Development & Optimization in Affected Pregnancies
| Status: | Recruiting |
|---|---|
| Conditions: | Other Indications |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/21/2016 |
| Start Date: | November 2009 |
| End Date: | June 2017 |
Noninvasive Screening for Fetal Chromosomal Aneuploidy and Abnormality: Assay Development & Optimization in Affected Pregnancies
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.
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.
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
We found this trial at
10
sites
Phoenix, Arizona 85013
Principal Investigator: John Garbaciak, MD
Phone: 602-263-0222
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Grand Rapids, Michigan 49503
Principal Investigator: Assad Sheikh, MD
Phone: 616-486-2085
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Honolulu, Hawaii 96814
Principal Investigator: Greigh I Hirata, MD
Phone: 858-945-2265
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350 W Thomas Rd
Phoenix, Arizona 85013
Phoenix, Arizona 85013
(602) 406-3000
Principal Investigator: James Balducci, MD
Phone: 602-406-6689
St. Joseph's Hospital and Medical Center St. Joseph's is a nationally recognized center for quality...
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101 Dudley St
Providence, Rhode Island 02905
Providence, Rhode Island 02905
(401) 274-1100
Principal Investigator: Barbara O'Brien, MD
Phone: 401-453-7515
Women and Infants Hospital of Rhode Island Women & Infants Hospital of Rhode Island, a...
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San Diego, California 91944
Principal Investigator: Christopher Lafferty, MD
Phone: 619-894-3028
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San Diego, California 92123
Principal Investigator: Larry Cousins, MD
Phone: 858-939-6880
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San Diego, California 92123
Principal Investigator: Rovena Reagan, MD
Phone: 858-505-8672
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Washington, District of Columbia 20036
Principal Investigator: Kristiann Nevin, MD
Phone: 202-331-1740
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