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NCGENES: North Carolina Clinical Genomic Evaluation by NextGen Exome Sequencing

NCT01969370 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 645

Last updated 2017-05-03

No results posted yet for this study

Summary

This study is part of a larger consortium project investigating the validity and best use of next-generation sequencing (in particular, whole exome sequencing, or WES) in clinical care. This sub-project is investigating benefits and harms of providing WES diagnostic and different types of incidental findings to adult patients and parents of pediatric patients who undergo WES because they have symptoms suggesting genetic disease.

Conditions

Interventions

BEHAVIORAL

Experimental

Option to request non-medically actionable incidental information (after receiving education about them)

Sponsors & Collaborators

  • National Human Genome Research Institute (NHGRI)

    collaborator NIH

  • UNC Lineberger Comprehensive Cancer Center

    collaborator OTHER

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • James P Evans, MD, Ph.D · University of North Carolina, Chapel Hill

  • Gail Henderson, Ph.D · University of North Carolina

  • Jonathan S Berg, MD, Ph.D · University of North Carolina

  • Christine Rini, Ph.D · University of North Carolina

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2017-03-01
Completion
2017-03-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01969370 on ClinicalTrials.gov