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

May 9, 2012
January 16, 2014
July 2012
June 2014   (final data collection date for primary outcome measure)
Estimate the false positive rate of SEQureDx Trisomy 21 Test [ Time Frame: pregnancy outcome ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT01597063 on ClinicalTrials.gov Archive Site
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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

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.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

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

Probability Sample

Pregnant with low risk for fetal chromosome 21 aneuploidy

  • Aneuploidy
  • Down Syndrome
  • Noninvasive Prenatal Screening
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.
low risk pregnancies
Intervention: Device: SEQureDx Trisomy Test

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
3000
June 2014
June 2014   (final data collection date for primary outcome measure)

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
Female
18 Years to 34 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01597063
SQNM-T21-303
No
Sequenom, Inc.
Sequenom, Inc.
Not Provided
Not Provided
Sequenom, Inc.
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP