Clinical Evaluation of the SEQureDx Trisomy Test in Low Risk Pregnancies
A Clinical Study to Evaluate the Relative Clinical Specificity Performance of the SEQureDx Trisomy Test in Pregnant Women at Low Risk for Fetal Chromosomal Aneuploidy
1 other identifier
observational
3,333
1 country
27
Brief Summary
Pregnant women with low risk indicators for fetal chromosomal aneuploidy will be enrolled. Study blood will be collected in the first or second trimester at a scheduled prenatal screening visit, processed to plasma, and stored frozen until analysis. Each pregnancy will be followed until delivery and the birth outcome recorded.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2012
Typical duration for all trials
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 9, 2012
CompletedFirst Posted
Study publicly available on registry
May 11, 2012
CompletedStudy Start
First participant enrolled
July 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedApril 20, 2016
April 1, 2016
1.6 years
May 9, 2012
April 18, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Estimate the false positive rate of SEQureDx Trisomy 21 Test
pregnancy outcome
Study Arms (1)
low risk pregnancies
Interventions
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
Pregnant with low risk for fetal chromosome 21 aneuploidy
You may qualify if:
- Pregnancy is 10-22 weeks gestation
- 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
You may not qualify if:
- Fetal demise at the time of the blood draw
- Previous specimen donation under this protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sequenom, Inc.lead
Study Sites (27)
University of South Alabama
Mobile, Alabama, 36604-3302, United States
New Horizon Women's Care
Chandler, Arizona, 85224, United States
Precision Trials
Phoenix, Arizona, 85032, United States
Visions Clinical Research Tuscon
Tucson, Arizona, 85712, United States
Descanso OBGYN
Glendale, California, 91208, United States
Woodglen Medical Group
Glendora, California, 91740, United States
White Memorial GYN/OB Medical Group
Los Angeles, California, 91740, United States
Fair Oaks Women's Health
Pasadena, California, 91105, United States
IGO Medical Group
San Diego, California, 92121, United States
West Coast OBGYN
San Diego, California, 92123, United States
Women's Health Care Research
San Diego, California, 92123, United States
Women's Clinical Research
Vista, California, 92081, United States
Hawaii Pacific Health
Honolulu, Hawaii, 96813, United States
University of Iowa Health Care
Iowa City, Iowa, 52242, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Spectrum Health - Maternal Fetal Medicine
Grand Rapids, Michigan, 49503, United States
William Beaumont Hospital
Royal Oak, Michigan, 48073, United States
Virtua Health
Moorestown, New Jersey, 08057, United States
Virtua Health
Mount Holly, New Jersey, 08060, United States
Jersey Shore University Medical Center
Neptune City, New Jersey, 07753, United States
Saint Peter's Hospital
New Brunswick, New Jersey, 08901, United States
Virtua Health
Sewell, New Jersey, 08080, United States
Virtua Health
Voorhees Township, New Jersey, 08043, United States
Providence Health Partners - Center for Clinical Research
Dayton, Ohio, 45439, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Medical University of South Carolina
Charleston, South Carolina, 29466, United States
Magnolia OB/GYN Research Center- Recruiting
Myrtle Beach, South Carolina, 29572, United States
Related Publications (3)
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.
PMID: 22005709BACKGROUNDEhrich 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.
PMID: 21310373BACKGROUNDPalomaki 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.
PMID: 22281937BACKGROUND
Biospecimen
Whole blood specimens will be collected and processed to plasma. DNA will be extracted from the plasma.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Daniel Grossu, MD
Sequenom, Inc.
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 9, 2012
First Posted
May 11, 2012
Study Start
July 1, 2012
Primary Completion
February 1, 2014
Study Completion
December 1, 2015
Last Updated
April 20, 2016
Record last verified: 2016-04
Data Sharing
- IPD Sharing
- Will share
Upon analysis of collected samples and submission for publication, data will be shared as per journal requirements.