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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00877292
Registration number
NCT00877292
Ethics application status
Date submitted
6/04/2009
Date registered
7/04/2009
Date last updated
3/06/2015
Titles & IDs
Public title
A New Prenatal Blood Test for Down Syndrome
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Scientific title
The RNA (RNA-Based Noninvasive Aneuploidy) Study
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Secondary ID [1]
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09-0004
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Universal Trial Number (UTN)
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Trial acronym
RNA
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Down Syndrome
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Trisomy 21
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Condition category
Condition code
Human Genetics and Inherited Disorders
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Down's syndrome
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Other
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Human Genetics and Inherited Disorders
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Other human genetics and inherited disorders
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Down syndrome - Women having CVS or amniocentesis who, as a group, have a high prevalence of Down syndrome.
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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The RNA study is an observational trial whose primary aim is to document the performance (sensitivity and specificity) of a laboratory developed test (LDT), using fetal nucleic acid in maternal plasma to identify Down syndrome in early pregnancy.
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Assessment method [1]
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Timepoint [1]
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Within 1st and 2nd trimesters
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Secondary outcome [1]
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The secondary aim is to develop a sample bank to allow documentation of subsequent improvements in the existing LDT or documenting performance of new methodologies.
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Assessment method [1]
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Timepoint [1]
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Late1st and early 2nd trimesters
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Eligibility
Key inclusion criteria
- 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:
1. the combined test at 10 to 13 weeks (NT, PAPP-A and hCG)
2. the second trimester quadruple test at 15 to 18 weeks gestation
3. 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).
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Nonpregnant women and women at relatively low risk for a Down syndrome baby.
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Study design
Purpose
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Duration
Cross-sectional
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Selection
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Timing
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/02/2009
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/05/2011
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Sample size
Target
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Accrual to date
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Final
4664
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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University of Sydney - St. Leonards
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Recruitment postcode(s) [1]
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2065 - St. Leonards
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Recruitment outside Australia
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United States of America
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Alabama
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California
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Connecticut
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Illinois
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Iowa
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Massachusetts
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Michigan
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Rhode Island
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Texas
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Utah
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Virginia
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Argentina
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Buenos Aires
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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Nova Scotia
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Canada
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Ontario
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Czech Republic
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Zlinsky kraj
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Czech Republic
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Ceske Budejovice
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Hungary
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Budapest
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Hungary
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Pecs
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Ireland
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Dublin
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Israel
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Haifa
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Italy
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Genova
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Spain
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Catalonia
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Funding & Sponsors
Primary sponsor type
Other
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Name
Women and Infants Hospital of Rhode Island
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Address
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Sequenom, Inc.
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Ethics approval
Ethics application status
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Summary
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 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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00877292
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Barbara O'Brien, MD
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Address
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Women and Infants Hospital
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00877292
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