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

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Trial Summary
Trial Overview
Inclusion Criteria

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.


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
Spectrum Health
Grand Rapids, Michigan 49503
Principal Investigator: Assad Sheikh, MD
Phone: 616-486-2085
1840
mi
from 91732
Grand Rapids, MI
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Fetal Diagnostic Institute of the Pacific
Honolulu, Hawaii 96814
Principal Investigator: Greigh I Hirata, MD
Phone: 858-945-2265
2572
mi
from 91732
Honolulu, HI
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Perinatal Care Associates
Phoenix, Arizona 85013
Principal Investigator: John Garbaciak, MD
Phone: 602-263-0222
342
mi
from 91732
Phoenix, AZ
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St. Joseph's Hospital and Medical Center
350 W Thomas Rd
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...
342
mi
from 91732
Phoenix, AZ
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Women and Infants Hospital of Rhode Island
101 Dudley St
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...
2562
mi
from 91732
Providence, RI
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Sharp Grossmount
San Diego, California 91944
Principal Investigator: Christopher Lafferty, MD
Phone: 619-894-3028
99
mi
from 91732
San Diego, CA
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IGO
San Diego, California 92121
Principal Investigator: Wendy Buchi, Md
Phone: 858-455-1248
93
mi
from 91732
San Diego, CA
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San Diego Perinatal Center
San Diego, California 92123
Principal Investigator: Larry Cousins, MD
Phone: 858-939-6880
101
mi
from 91732
San Diego, CA
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Women's Healthcare at Frost Street
San Diego, California 92123
Principal Investigator: Rovena Reagan, MD
Phone: 858-505-8672
101
mi
from 91732
San Diego, CA
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Reiter, Hill, Johnson and Nevin
Washington, District of Columbia 20036
Principal Investigator: Kristiann Nevin, MD
Phone: 202-331-1740
2281
mi
from 91732
Washington,
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