Clinical Evaluation of the SEQureDx T21 Test In High Risk Pregnancies
NCT ID: NCT01555346
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
3062 participants
OBSERVATIONAL
2012-03-31
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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High risk pregnant subjects undergoing an invasive procedure
Women with one or more high risk factors for fetal chromosome 21 aneuploidy scheduled to undergo an invasive procedure for fetal karyotype determination.
No interventions assigned to this group
High risk subjects electing not to undergo invasive procedure
Women with one or more high risk factors for fetal chromosome 21 aneuploidy who elect not to undergo an invasive procedure for fetal karyotype determination.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Subject has one or more high risk indicator for fetal chromosome 21 aneuploidy
* Subject provides signed and dated informed consent
* Subject agrees to provide a whole blood sample
Exclusion Criteria
* Previous specimen donation under this protocol
18 Years
60 Years
FEMALE
No
Sponsors
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Sequenom, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Juan-Sebastian Saldivar, MD
Role: STUDY_DIRECTOR
Sequenom Laboratories
Locations
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University of South Alabama
Mobile, Alabama, United States
Visions Clinical Research Tuscon
Tucson, Arizona, United States
Obstetrix Medical Group of California
Campbell, California, United States
Long Beach Memorial Medical Center
Long Beach, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
San Gabriel Valley Perinatal Medical Center
Monterey Park, California, United States
Scripps Clinic Carmel Valley
San Diego, California, United States
South Florida Perinatal
Miami, Florida, United States
Southeast Perinatal Associates - Miramar
Miramar, Florida, United States
Southeast Perinatal Associates - Weston
Sunrise, Florida, 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
Norton Healthcare
Louisville, Kentucky, United States
Willis-Knighton Physician Network
Shreveport, Louisiana, United States
University of Maryland
Baltimore, Maryland, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
Saint Lukes Hospital of Kansas City
Kansas City, Missouri, 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
University of Cincinnati
Cincinnati, Ohio, United States
Complete Healthcare for Women
Columbus, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Regional Obstetrical Consultants
Chatanooga, Tennessee, United States
Obstetrix Medical Group of Washington, Inc.
Seattle, Washington, United States
North York General Hospital
Toronto, Ontario, Canada
Chuq/Chul
Québec, Quebec, Canada
Countries
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References
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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.
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.
Other Identifiers
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SQNM-T21-304
Identifier Type: -
Identifier Source: org_study_id
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