Clinical Evaluation of the SEQureDx Trisomy Test in Low Risk Pregnancies

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sequenom, Inc.
ClinicalTrials.gov Identifier:
NCT01597063
First received: May 9, 2012
Last updated: January 16, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Aneuploidy
Down Syndrome
Noninvasive Prenatal Screening
Device: SEQureDx Trisomy Test

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Sequenom, Inc.:

Primary Outcome Measures:
  • Estimate the false positive rate of SEQureDx Trisomy 21 Test [ Time Frame: pregnancy outcome ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Whole blood specimens will be collected and processed to plasma. DNA will be extracted from the plasma.


Estimated Enrollment: 3000
Study Start Date: July 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
low risk pregnancies Device: 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

Ages Eligible for Study:   18 Years to 34 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Pregnant with low risk for fetal chromosome 21 aneuploidy

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Fetal demise at the time of the blood draw
  • Previous specimen donation under this protocol
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01597063

Locations
United States, Alabama
University of South Alabama
Mobile, Alabama, United States, 36604-3302
United States, Arizona
New Horizon Women's Care
Chandler, Arizona, United States, 85224
Precision Trials
Phoenix, Arizona, United States, 85032
Visions Clinical Research Tuscon
Tucson, Arizona, United States, 85712
United States, California
Descanso OBGYN
Glendale, California, United States, 91208
Woodglen Medical Group
Glendora, California, United States, 91740
White Memorial GYN/OB Medical Group
Los Angeles, California, United States, 91740
Fair Oaks Women's Health
Pasadena, California, United States, 91105
West Coast OBGYN
San Diego, California, United States, 92123
IGO Medical Group
San Diego, California, United States, 92121
Women's Health Care Research
San Diego, California, United States, 92123
Women's Clinical Research
Vista, California, United States, 92081
United States, Hawaii
Hawaii Pacific Health
Honolulu, Hawaii, United States, 96813
United States, Iowa
University of Iowa Health Care
Iowa City, Iowa, United States, 52242
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
United States, Michigan
Spectrum Health - Maternal Fetal Medicine
Grand Rapids, Michigan, United States, 49503
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
United States, New Jersey
Virtua Health
Moorestown, New Jersey, United States, 08057
Virtua Health
Mt. Holly, New Jersey, United States, 08060
Jersey Shore University Medical Center
Neptune, New Jersey, United States, 07753
Saint Peter's Hospital
New Brunswick, New Jersey, United States, 08901
Virtua Health
Sewell, New Jersey, United States, 08080
Virtua Health
Voorhees, New Jersey, United States, 08043
United States, Ohio
Providence Health Partners - Center for Clinical Research
Dayton, Ohio, United States, 45439
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29466
Magnolia OB/GYN Research Center- Recruiting
Myrtle Beach, South Carolina, United States, 29572
Sponsors and Collaborators
Sequenom, Inc.
  More Information

Publications:
Responsible Party: Sequenom, Inc.
ClinicalTrials.gov Identifier: NCT01597063     History of Changes
Other Study ID Numbers: SQNM-T21-303
Study First Received: May 9, 2012
Last Updated: January 16, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Aneuploidy
Down Syndrome
Trisomy
Chromosome Aberrations
Pathologic Processes
Mental Retardation
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn
Chromosome Duplication

ClinicalTrials.gov processed this record on July 10, 2014