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NCT02381457 · ClinicalTrials.gov registry record
SNP-based Microdeletion and Aneuploidy RegisTry (SMART)
A clinical trial, sponsored by Natera.
- Completed
- Registry status
- 20,960
- Enrollment target
NCT02381457: Completed study, sponsored by Natera.
NCT02381457 is a clinical trial that has completed, run by Natera. The registered enrollment target is 20,960 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02381457 has completed, sponsored by Natera.
- COMPLETED
- Registry status
- 20,960 participants
- Enrollment target
Study Summary
This multi-center prospective observational study is designed to track birth outcomes and perinatal correlates to the Panorama prenatal screening test in the general population among ten thousand women who present clinically and elect Panorama microdeletion and aneuploidy screening as part of their routine care. The primary objective is to evaluate the performance of Single Nucleotide Polymorphism (SNP)-based Non Invasive Prenatal Testing (NIPT) for 22q11.2 microdeletion (DiGeorge syndrome) in this large cohort of pregnant women. This will be done by performing a review of perinatal medical records and obtaining biospecimens after birth to perform genetic diagnostic testing for 22q11.2 deletion. Results from the follow-up specimens will be compared to those obtained by the Panorama screening test to determine test performance. Specific test performance parameters will include: PPV, specificity, and sensitivity.
Primary Outcome
To determine in a prospective study the performance of SNP based NIPT for the 22q11.2 microdeletion (DiGeorge syndrome) in a large cohort of pregnant women clinically opting for this form of screening.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20,960 participants |
| Start Date | 2015-04 |
| Est. Completion | 2020-06 |
What the finished NCT02381457 record still lists
NCT02381457 is an observational study that tracks outcomes without assigning an intervention. Its 20,960 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 0 interventions.
NCT02381457 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02381457 about?
NCT02381457 is a clinical study titled "SNP-based Microdeletion and Aneuploidy RegisTry (SMART)". This multi-center prospective observational study is designed to track birth outcomes and perinatal correlates to the Panorama prenatal screening test in the general population among ten thousand women who present clinically and elect Panorama microdeletion and aneuploidy screening as part of their ...
What is the current status of trial NCT02381457?
This trial is currently completed. The enrollment target is 20,960 participants. The study started on 2015-04. Estimated completion is 2020-06.
Who is sponsoring clinical trial NCT02381457?
This trial is sponsored by Natera, which has 27 total clinical trials registered on ClinicalTrials.gov.
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