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NCT03290469 · ClinicalTrials.gov registry record · NA
NICUSeq: A Trial to Evaluate the Clinical Utility of Human Whole Genome Sequencing (WGS) Compared to Standard of Care in Acute Care Neonates and Infants
A NA study of Rare Diseases, sponsored by Illumina.
- Completed
- Registry status
- NA
- Development phase
- 355
- Enrollment target
- 5
- Study locations
NCT03290469: Completed NA study of Rare Diseases, sponsored by Illumina.
NCT03290469 is a NA study of Rare Diseases that has completed, run by Illumina. The registered enrollment target is 355 participants, below the 17,425-participant average among 7 other Rare Diseases trials with a reported enrollment target (98% lower). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03290469, a NA study of Rare Diseases, has completed, sponsored by Illumina.
- COMPLETED
- Registry status
- NA
- Development phase
- 355 participants
- Enrollment target
- 5
- Study locations
Study Summary
Prospective, multi-site, study to evaluate the clinical utility of cWGS in a proband. One group will receive cWGS and a clinical report approximately 15 days after blood samples are received, while the other group will continue to receive standard of care until Day 60. The standard of care group will receive cWGS and a clinical report at Day 60 as part of secondary and tertiary analyses. Both groups will be followed for a total of 90 days.
Primary Outcome
Change of Management is a binary (yes or no) based on assignments made by the PI or designee at each site using the following domains: * Condition specific management * Condition specific supportive interventions * Palliative care/End of Life Care A change in any of these domains will be considered a change of management.
Conditions Studied
Interventions
- OTHER clinical whole genome sequencing (cWGS)
Study Locations (5)
California
- Rady's/Children's Hospital of Orange County - Orange
Missouri
- Washington University in St. Louis School of Medicine & St. Louis Children's Hospital - St Louis
Nebraska
- University of Nebraska Medical Center & Children's Hospital - Omaha
Pennsylvania
- Children's Hospital of Philadelpia - Philadelphia
Tennessee
- LeBonheur Hospital - Memphis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 355 participants |
| Start Date | 2017-09-14 |
| Est. Completion | 2020-01-13 |
| Phase | NA |
What the finished NCT03290469 record still lists
NCT03290469 is an interventional study that assigns participants to a tested intervention. The registered 355 participants enrollment target is mid-sized for trials with a published cap, below the 17,425-participant average among 7 other Rare Diseases trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Rare Diseases appearing as the primary indexed condition, and to 1 intervention - of which clinical whole genome sequencing (cWGS) is the first listed.
NCT03290469 lists 5 locations in 5 states (California, Missouri, Nebraska).
Frequently Asked Questions
What is clinical trial NCT03290469 about?
NCT03290469 is a clinical study titled "NICUSeq: A Trial to Evaluate the Clinical Utility of Human Whole Genome Sequencing (WGS) Compared to Standard of Care in Acute Care Neonates and Infants". Prospective, multi-site, study to evaluate the clinical utility of cWGS in a proband. One group will receive cWGS and a clinical report approximately 15 days after blood samples are received, while the other group will continue to receive standard of care until Day 60. The standard of care group wil...
What is the current status of trial NCT03290469?
This trial is currently completed. It is a NA study. The enrollment target is 355 participants. The study started on 2017-09-14. Estimated completion is 2020-01-13.
What conditions does trial NCT03290469 study?
This clinical trial studies the following conditions: Rare Diseases.
What interventions are being tested in trial NCT03290469?
The interventions under investigation include: clinical whole genome sequencing (cWGS) (OTHER).
Who is sponsoring clinical trial NCT03290469?
This trial is sponsored by Illumina, which has 11 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03290469 being conducted?
This trial has 5 study locations across California, Missouri, Nebraska, Pennsylvania, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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