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NCT01555346 · ClinicalTrials.gov registry record
Clinical Evaluation of the SEQureDx T21 Test In High Risk Pregnancies
A clinical trial of Down Syndrome and Fetal Aneuploidy, sponsored by Sequenom.
- Completed
- Registry status
- 3,062
- Enrollment target
- 20
- Study locations
NCT01555346: Completed study of Down Syndrome and Fetal Aneuploidy, sponsored by Sequenom.
NCT01555346 is a study of Down Syndrome and Fetal Aneuploidy that has completed, run by Sequenom. The registered enrollment target is 3,062 participants, above the 2,415-participant average among 54 other Down Syndrome trials with a reported enrollment target (27% higher). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01555346, a study of Down Syndrome and Fetal Aneuploidy, has completed, sponsored by Sequenom.
- COMPLETED
- Registry status
- 3,062 participants
- Enrollment target
- 20
- Study locations
Study Summary
Whole blood samples will be collected from high-risk pregnant women to validate the clinical performance of the SEQureDx Trisomy 21 Test.
Primary Outcome
Each subject will provide a single blood sample prior to undergoing an amniocentesis/CVS that will be processed to plasma and stored frozen until the end of the study. Frozen plasma samples will then be analyzed using the SEQureDx Trisomy Test and the sensitivity and specificity of the assay will be determined by comparing the plasma test results to the fetal karyotyping results obtained via aminiocentesis or CVS. A subject's participation ends after the results of the fetal karyotype are obtain
Conditions Studied
Study Locations (20)
California
- Obstetrix Medical Group of California - Campbell
- Long Beach Memorial Medical Center - Long Beach
- Cedars-Sinai Medical Center - Los Angeles
- San Gabriel Valley Perinatal Medical Center - Monterey Park
- Scripps Clinic Carmel Valley - San Diego
Florida
- South Florida Perinatal - Miami
- Southeast Perinatal Associates - Miramar - Miramar
- Southeast Perinatal Associates - Weston - Sunrise
New Jersey
- Jersey Shore University Medical Center - Neptune City
- Saint Peter's Hospital - New Brunswick
Alabama
- University of South Alabama - Mobile
Arizona
- Visions Clinical Research Tuscon - Tucson
Hawaii
- Hawaii Pacific Health - Honolulu
Iowa
- University of Iowa Health Care - Iowa City
Kansas
- University of Kansas Medical Center - Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,062 participants |
| Start Date | 2012-03 |
| Est. Completion | 2015-12 |
What the finished NCT01555346 record still lists
NCT01555346 is an observational study that tracks outcomes without assigning an intervention. Its 3,062 participants enrollment target places it among the larger protocols in the corpus, above the 2,415-participant average among 54 other Down Syndrome trials with a reported enrollment target (27% higher).
The record links to 2 conditions, with Down Syndrome appearing as the primary indexed condition, and to 0 interventions.
NCT01555346 names 20 study sites across 13 states, led by California, Florida, New Jersey.
Frequently Asked Questions
What is clinical trial NCT01555346 about?
NCT01555346 is a clinical study titled "Clinical Evaluation of the SEQureDx T21 Test In High Risk Pregnancies". Whole blood samples will be collected from high-risk pregnant women to validate the clinical performance of the SEQureDx Trisomy 21 Test.
What is the current status of trial NCT01555346?
This trial is currently completed. The enrollment target is 3,062 participants. The study started on 2012-03. Estimated completion is 2015-12.
What conditions does trial NCT01555346 study?
This clinical trial studies the following conditions: Down Syndrome, Fetal Aneuploidy.
Who is sponsoring clinical trial NCT01555346?
This trial is sponsored by Sequenom, which has 26 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01555346 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Florida, Hawaii. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01555346's enrollment target sits among peer trials
3,062 4th of 54 higher than 51 of 54 other Down Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Down Syndrome trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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