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A New Prenatal Blood Test for Down Syndrome

NCT00877292 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 4664

Last updated 2015-06-03

No results posted yet for this study

Summary

The study will examine the sensitivity and specificity of a circulating cell-free nucleic acid test (DNA/RNA) to identify Down syndrome between about 10 weeks and 21 weeks 6 days gestation. In addition, the new test may be used to identify trisomy 13 and 18 as part of a more complete laboratory developed test. We hypothesize that the new circulating cell-free fetal NA-based test will accurately and precisely measure specific fetal markers in maternal circulation and that measurement will lead to the ability to noninvasively identify with high sensitivity and specificity, fetal chromosome abnormalities, such as Down syndrome.

Conditions

  • Down Syndrome
  • Trisomy 21

Sponsors & Collaborators

  • Sequenom, Inc.

    collaborator INDUSTRY

  • Women and Infants Hospital of Rhode Island

    lead OTHER

Principal Investigators

  • Barbara O'Brien, MD · Women and Infants Hospital

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2011-01-31
Completion
2011-05-31

Countries

  • United States
  • Argentina
  • Australia
  • Canada
  • Czechia
  • Hungary
  • Ireland
  • Israel
  • Italy
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00877292 on ClinicalTrials.gov