Non-Invasive Determination of Fetal Chromosome Abnormalities
Status unconfirmed
Conditions studied: Down Syndrome (Trisomy 21), Edward's Syndrome (Trisomy 18), Patau Syndrome (Trisomy 13), Klinefelter Syndrome (47, XXY), and Other Chromosome, Abnormalities.
In brief
The overall significance of this study is to develop a laboratory developed test (LDT) to use a new marker in the maternal blood to better identify pregnancies that have a child with a chromosome abnormality such as Down syndrome (trisomy 21), Edward's syndrome (trisomy 18), Patau syndrome (trisomy 13), Klinefelter syndrome, (47, XXY), and other chromosome abnormalities. Accomplishing that task would reduce the need for invasive amniocentesis and CVS procedures.
Key facts
- Study ID
- NCT00891852
- Run by
- Lenetix Medical Screening Laboratory
- People needed
- 1000
- Starts
- 2009-01-01
- Expected to finish
- 2009-12-01
- Last updated by the study team
- 2009-05-01
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- This study is only applicable to women who are between 8 and 30 weeks' gestation and who have been determined increased risk for fetal aneuploidy. In the interest of expediting and simplifying this study, the investigators want only women who have already decided to undergo second-trimester amniocentesis or CVS.
You may not qualify if…
- The only exclusion criteria are those mentioned.
Where it is running
- Maryland Perinatal Associates — Rockville, Maryland, United States (enrolling)
- Atlantic Maternal Fetal Medicine — Moristown, New Jersey, United States (enrolling)
- Winthrop University Hospital — Mineola, New York, United States (enrolling)
- Elite Women's Health — New Hyde Park, New York, United States (enrolling)
- Columbia University, NewYork-Presbyterian Hospital — New York, New York, United States (enrolling)
- New York Perinatal Associates — New York, New York, United States (enrolling)
- UVM — Burlington, Vermont, United States (enrolling)
Full record on ClinicalTrials.gov
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