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NCT03548779 · ClinicalTrials.gov registry record · NA

North Carolina Genomic Evaluation by Next-generation Exome Sequencing, 2

A NA study, sponsored by University of North Carolina, Chapel Hill.

Completed
Registry status
NA
Development phase
548
Enrollment target

NCT03548779: Completed NA study, sponsored by University of North Carolina, Chapel Hill.

NCT03548779 is a NA study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 548 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (61% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03548779, a NA study, has completed, sponsored by University of North Carolina, Chapel Hill.

COMPLETED
Registry status
NA
Development phase
548 participants
Enrollment target

Study Summary

The "North Carolina Clinical Genomic Evaluation by Next-gen Exome Sequencing, 2 (NCGENES 2)" study is part of a larger consortium project investigating the clinical utility, or net benefit of an intervention on patient and family well-being as well as diagnostic efficacy, management planning, and medical outcomes. A clinical trial will be implemented to compare (1) first-line exome sequencing to usual care and (2) participant pre-visit preparation to no pre-visit preparation. The study will use a randomized controlled design, with 2x2 factorial design, coupled with patient-reported outcomes and comprehensive clinical data collection addressing key outcomes, to determine the net impact of diagnostic results and secondary findings.

Primary Outcome

The Peds QL Measurement Model for the Pediatric Quality of Inventory measures the core dimensions of health as delineated by the World Health Organization as well as role (school) functioning. The 23-item PedsQL Core Scales (Physical Functioning, Emotional Functioning, Social Functioning, and School Functioning) are developmentally appropriate surveys (Ages 2-4, 5-7, 8-12, 13-18) designed for parent proxy report. The 23 items are grouped together on the questionnaire, and are answered on a scale

Interventions

  • BEHAVIORAL Pre-visit prep
  • DIAGNOSTIC_TEST usual care + exome seq

Trial Details

FieldValue
Enrollment Target 548 participants
Start Date 2018-09-28
Est. Completion 2024-09-08
Phase NA

What the finished NCT03548779 record still lists

NCT03548779 is an interventional study that assigns participants to a tested intervention. The registered 548 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (61% lower).

The record links to 0 conditions, and to 2 interventions - of which Pre-visit prep is the first listed.

NCT03548779 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03548779 about?

NCT03548779 is a clinical study titled "North Carolina Genomic Evaluation by Next-generation Exome Sequencing, 2". The "North Carolina Clinical Genomic Evaluation by Next-gen Exome Sequencing, 2 (NCGENES 2)" study is part of a larger consortium project investigating the clinical utility, or net benefit of an intervention on patient and family well-being as well as diagnostic efficacy, management planning, and me...

What is the current status of trial NCT03548779?

This trial is currently completed. It is a NA study. The enrollment target is 548 participants. The study started on 2018-09-28. Estimated completion is 2024-09-08.

What interventions are being tested in trial NCT03548779?

The interventions under investigation include: Pre-visit prep (BEHAVIORAL), usual care + exome seq (DIAGNOSTIC_TEST).

Who is sponsoring clinical trial NCT03548779?

This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03548779's enrollment target sits among peer trials

548 186th of 2000 higher than 1,815 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA 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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Source: ClinicalTrials.gov NCT03548779, the US trial registry maintained by the National Library of Medicine. NCT03548779 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.