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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 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.

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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.

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

FieldValue
Enrollment Target 355 participants
Start Date 2017-09-14
Est. Completion 2020-01-13
Phase NA

Sponsor

Illumina

11 total trials

What the Registry Record Tells You About NCT03290469

The ClinicalTrials.gov registry entry for NCT03290469 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 355 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 17,425-participant average among 7 other Rare Diseases trials with a reported enrollment target (98% lower). The listed sponsor is Illumina, which has 11 total studies on file at ClinicalTrials.gov.

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 reports 5 study locations spanning 5 distinct geographic areas - top geographies include 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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.