An observational study in Down Syndrome (Trisomy 21), Edward's Syndrome (Trisomy 18) and Patau Syndrome (Trisomy 13), sponsored by Lenetix Medical Screening Laboratory. Status unknown at 7 sites in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-05-01.
Sponsored by Lenetix Medical Screening Laboratory · Observational
Among 204 studies in Down Syndrome with a site in United States — 47 open to participants now, 55 under way, 4 of them phase 3. Down Syndrome · United States.
Among the 204 studies in Down Syndrome with a site in United States, this one is the 25th largest by planned enrollment of the 74 observational ones, is one of 11 that started in 2009, is one of 74 observational ones, and was the 19th registered.
438 studies on the registry are indexed under Down Syndrome; 99 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 158 across 145 observational studies indexed under Down Syndrome.
Browse Down Syndrome studies →47 of the 204 studies in Down Syndrome with a site in United States are open now, in 9 countries. Each count lists the studies.
Of the 75 Down Syndrome studies recruiting now, 14 (19%) set no upper age limit and 58 (77%) stop at 75 or younger; 61 take children under 18; 19 take healthy volunteers.
This study: 18 Years and older · female · healthy volunteers too.
The full table on the hub →204 studies; the count open now beside each. This study's row is marked.
First in 1981; this study’s year is marked. 11 started in 2009.
Median enrollment 40 across the 130 interventional studies, 433 across the 74 observational. Of the 139 that completed or were terminated, 42 (30%) have results posted.
47 of 204 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with Lenetix Medical Screening Laboratory as lead sponsor.
Lenetix Medical Screening Laboratory has 1 study filed under Down Syndrome — fewer than ten, so there is no comparison to draw.
14 of the studies in Down Syndrome with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03914625Phase 3National Cancer Institute (NCI)A Study to Investigate Blinatumomab in Combination With Chemotherapy in Patients With Newly Diagnosed B-Lymphoblastic Leukemia | 2027-09-30 |
| NCT04278404Duke UniversityPharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS) | 2026-11 |
| NCT07008989Boston CollegeA VIRTUAL Three-month Intervention Study of the Effects of a Smartphone Application (HippoCamera) on Memory in Teens and Young Adults With Down Syndrome | 2026-12-31 |
| NCT05196984Massachusetts Institute of TechnologyGamma Frequency Stimulation in Individuals With Down Syndrome | 2026-12-31 |
| NCT03233646Duke UniversityRetinal Imaging in Neurodegenerative Disease | 2026-12-31 |
Among the 204 studies in Down Syndrome with a site in United States, from their registry updates:
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.
The investigators anticipate enrolling 1000 subjects who are presenting for prenatal diagnosis by CVS or genetic amniocentesis for increased risk for fetal aneuploidy.
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Exclusion Criteria:
The record gives a start of Jan 2009, a primary completion of Dec 2009 and a completion of Dec 2009. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Apr 2009. You cannot join it, but the record below documents what was studied.
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