Status:
COMPLETED
A New Prenatal Blood Test for Down Syndrome
Lead Sponsor:
Women and Infants Hospital of Rhode Island
Collaborating Sponsors:
Sequenom, Inc.
Conditions:
Down Syndrome
Trisomy 21
Eligibility:
FEMALE
18+ years
Brief 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 additio...
Detailed Description
The RNA study is an observational trial whose primary aim is to document the performance (sensitivity and specificity) of one or more laboratory developed test (LDT) using circulating cell-free fetal ...
Eligibility Criteria
Inclusion
- Pregnant women between about 10 weeks and 21 weeks 6 days gestation who are undergoing a diagnostic procedure (i.e., chorionic villus sampling or amniocentesis) for karyotype analysis who have, on average, a high prevalence of Down syndrome (about 1:30 to 1:50).
- Three main sources are pregnancies screen positive for:
- the combined test at 10 to 13 weeks (NT, PAPP-A and hCG)
- the second trimester quadruple test at 15 to 18 weeks gestation
- integrated screening (PAPP-A and the quadruple test, with or without NT).
- Variations of the integrated test such as sequential testing will also be acceptable.
- Other, less common high risk groups would be women having diagnostic testing because of maternal age of 38 years or older at delivery, pregnancies with an abnormal ultrasound highly suggestive of a chromosome abnormality (e.g., major heart defect, clenched fist), and women with an inherited form of Down syndrome (Robertsonian translocation).
Exclusion
- Nonpregnant women and women at relatively low risk for a Down syndrome baby.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
4664 Patients enrolled
Trial Details
Trial ID
NCT00877292
Start Date
February 1 2009
End Date
May 1 2011
Last Update
June 3 2015
Active Locations (27)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
2
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
3
Yale University School of Medicine
New Haven, Connecticut, United States, 06520
4
Northwestern University, FSM
Chicago, Illinois, United States, 60611