Clinical Evaluation of the SEQureDx Trisomy Test in Low Risk Pregnancies
NCT ID: NCT01597063
Last Updated: 2016-04-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
3333 participants
OBSERVATIONAL
2012-07-31
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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low risk pregnancies
SEQureDx Trisomy Test
Plasma samples obtained from maternal blood will be tested using the SEQureDx Trisomy Test, an in vitro diagnostic test that measures circulating cell-free fetal DNA. The test detects the relative quantity of chromosome 21, which is associated with trisomy 21.
Interventions
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SEQureDx Trisomy Test
Plasma samples obtained from maternal blood will be tested using the SEQureDx Trisomy Test, an in vitro diagnostic test that measures circulating cell-free fetal DNA. The test detects the relative quantity of chromosome 21, which is associated with trisomy 21.
Eligibility Criteria
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Inclusion Criteria
* Between 18-34 years of age inclusive at estimated date of delivery
* No prenatal screening indicators for high risk including serum biochemical and ultrasound screening
* No personal or family history of Down syndrome
* Willing to provide written informed consent
* Willing to provide a whole blood sample
* Willing to provide access to medical records supporting fetal outcome
Exclusion Criteria
* Previous specimen donation under this protocol
18 Years
34 Years
FEMALE
No
Sponsors
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Sequenom, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Daniel Grossu, MD
Role: STUDY_DIRECTOR
Sequenom, Inc.
Locations
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University of South Alabama
Mobile, Alabama, United States
New Horizon Women's Care
Chandler, Arizona, United States
Precision Trials
Phoenix, Arizona, United States
Visions Clinical Research Tuscon
Tucson, Arizona, United States
Descanso OBGYN
Glendale, California, United States
Woodglen Medical Group
Glendora, California, United States
White Memorial GYN/OB Medical Group
Los Angeles, California, United States
Fair Oaks Women's Health
Pasadena, California, United States
IGO Medical Group
San Diego, California, United States
West Coast OBGYN
San Diego, California, United States
Women's Health Care Research
San Diego, California, United States
Women's Clinical Research
Vista, California, United States
Hawaii Pacific Health
Honolulu, Hawaii, United States
University of Iowa Health Care
Iowa City, Iowa, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Spectrum Health - Maternal Fetal Medicine
Grand Rapids, Michigan, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
Virtua Health
Moorestown, New Jersey, United States
Virtua Health
Mount Holly, New Jersey, United States
Jersey Shore University Medical Center
Neptune City, New Jersey, United States
Saint Peter's Hospital
New Brunswick, New Jersey, United States
Virtua Health
Sewell, New Jersey, United States
Virtua Health
Voorhees Township, New Jersey, United States
Providence Health Partners - Center for Clinical Research
Dayton, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Magnolia OB/GYN Research Center- Recruiting
Myrtle Beach, South Carolina, United States
Countries
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References
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Palomaki GE, Kloza EM, Lambert-Messerlian GM, Haddow JE, Neveux LM, Ehrich M, van den Boom D, Bombard AT, Deciu C, Grody WW, Nelson SF, Canick JA. DNA sequencing of maternal plasma to detect Down syndrome: an international clinical validation study. Genet Med. 2011 Nov;13(11):913-20. doi: 10.1097/GIM.0b013e3182368a0e.
Ehrich M, Deciu C, Zwiefelhofer T, Tynan JA, Cagasan L, Tim R, Lu V, McCullough R, McCarthy E, Nygren AO, Dean J, Tang L, Hutchison D, Lu T, Wang H, Angkachatchai V, Oeth P, Cantor CR, Bombard A, van den Boom D. Noninvasive detection of fetal trisomy 21 by sequencing of DNA in maternal blood: a study in a clinical setting. Am J Obstet Gynecol. 2011 Mar;204(3):205.e1-11. doi: 10.1016/j.ajog.2010.12.060. Epub 2011 Feb 18.
Palomaki GE, Deciu C, Kloza EM, Lambert-Messerlian GM, Haddow JE, Neveux LM, Ehrich M, van den Boom D, Bombard AT, Grody WW, Nelson SF, Canick JA. DNA sequencing of maternal plasma reliably identifies trisomy 18 and trisomy 13 as well as Down syndrome: an international collaborative study. Genet Med. 2012 Mar;14(3):296-305. doi: 10.1038/gim.2011.73. Epub 2012 Feb 2.
Other Identifiers
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SQNM-T21-303
Identifier Type: -
Identifier Source: org_study_id
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