Development of a Next Generation Sequencing (NGS) -Based Assay to Detect Preeclampsia Molecular Markers



Status:Recruiting
Conditions:Women's Studies, Women's Studies
Therapuetic Areas:Reproductive
Healthy:No
Age Range:18 - Any
Updated:3/2/2017
Start Date:March 2016
End Date:December 2017
Contact:Kevin O'Shea
Email:koshea@illumina.com
Phone:6502042231

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Prospective Collection of Whole Blood Specimens of Subjects Diagnosed With Preterm Preeclampsia and/or Fetal Growth Restriction in Support of a Molecular Assay Development

Sample Collection Study

This is a limited prospective collection of whole blood samples from pregnant women with a
diagnosis of preterm preeclampsia and/or fetal growth restriction in addition to samples
from a control group to aid in the development of a Next Generation Sequencing (NGS)-based
assay to detect molecular markers associated with preterm preeclampsia.

Inclusion Criteria:

- Women 18 years of age or older at enrollment

- Pregnant women with a viable singleton gestation

- Able to provide written, informed consent

- Able to provide 20 mL of whole blood

- Diagnosis of preeclampsia and/or diagnosis of fetal growth restriction

- Preeclampsia; Diastolic Blood Pressure ≥110mmHg on at least 2 occasions 4 hours apart
while on bed rest, but before the onset of labor with Proteinuria; Excretion of
≥300mg/24hr (24 hour collection) of protein or a timed excretion that is extrapolated
to the 24 hour urine value or a protein/creatinine [both in mg/dL] ratio of at least
0.3 or the qualitative determination (urine dipstick) of ≥ 1+

- Fetal Growth Restriction; Estimated fetal weight or abdominal circumference by
ultrasound at ≥ 19 0/7 weeks gestational age < 5%ile or 5-10%ile with abnormal
umbilical artery Doppler examination (>95%ile, absent end diastolic flow or reverse
end diastolic flow)

- Gestational age between 20 to 36 weeks 6 days determined by ultrasound and/or LMP per
ACOG guidelines1

Exclusion Criteria:

- Known malignancy

- History of maternal organ or bone marrow transplant

- Maternal blood transfusion in the last 8 weeks

- Any hypertension diagnosed prior to current pregnancy

- Diabetes

- Fetal anomaly or known chromosome abnormality

- Thrombocytopenia (< 100,000 plts/mL)

- Impaired liver function (AST/ALT 2X ULN)

- Newly developed renal insufficiency (serum creatinine >1.1 mg/dL or a doubling of
serum creatinine in the absence of other renal disease)

- Pulmonary edema

- New onset cerebral disturbances or visual scotomata
We found this trial at
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sites
254 Easton Ave
New Brunswick, New Jersey 08901
(732) 745-8600
Principal Investigator: Angela Ranzini
Phone: 732-339-7602
Saint Peter's University Hospital Located in New Brunswick, NJ, Saint Peter's University Hospital has been...
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800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
Principal Investigator: Errol Norwitz, MD
Phone: 617-636-0186
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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Boston, MA
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301 University Blvd
Galveston, Texas 77555
(409) 772-1011
Principal Investigator: George Saade, MD
University of Texas Medical Branch Established in 1891 as the University of Texas Medical Department,...
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Flushing, New York 11355
Principal Investigator: Daniel Skupski
Phone: 718-670-1707
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Flushing, NY
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New York, New York 10065
Principal Investigator: Ronald Wapner
Phone: 212-305-2158
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259 1st Street
New York, New York 11501
Principal Investigator: Jolene Muscat
Phone: 510-663-9582
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New York, NY
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Newark, Delaware 19718
Principal Investigator: Kelly Ruhstaller
Phone: 302-733-2379
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1427 Vine Street
Philadelphia, Pennsylvania 19102
Principal Investigator: Lauren Plante
Phone: 215-762-8582
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Piscataway, New Jersey 08854
Principal Investigator: Christina Duzyj-Buniak
Phone: 732-235-6630
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239 Hurffville Crosskeys Road
Sewell, New Jersey 08080
Principal Investigator: Ronald Librizzi
Phone: 856-291-8875
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