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

Trial Information
Status: Active, not recruiting
Location: See all (3) locations...
Intervention Type: Behavioral, Diagnostic Test
Study Type: Interventional
Study Phase: Not Applicable
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.

Am I eligible for this trial?
Participation Requirements
Sex:
All
Healthy Volunteers:
No

• Parents meeting the following criteria:

• Parent of a child who meets the criteria below

• At least 18 years old.

• Must be able to provide informed consent for child and self.

• Must be fluent in English or Spanish.

• Children meeting the following criteria:

• Infants and children 15 years old or less.

• Referred for initial evaluation of a possible monogenic disorder OR

• Seen for evaluation of an undiagnosed disorder in a study-associated clinic.

Where is this trial taking place?
United States
North Carolina
Mission Health
Asheville
University of North Carolina at Chapel Hill
Chapel Hill
East Carolina University
Greenville
When is this trial taking place?
Start Date: September 28, 2018
Estimated Completion Date: May 2023
How many participants will be in this trial?
Target number of participants: 806
What treatment is being studied in this trial?
Experimental: Pre-visit prep / usual care + exome seq
Participants randomized to pre-visit prep will receive a study packet with educational materials and a question prompt list. These participants will be instructed to review the materials, discuss them with family members if desired, use the question prompt list to select questions they would like to ask at clinic visit 1, and bring the list to their clinic visit 1 appointment.~Participants will receive usual care and will be offered research exome sequencing.
Experimental: Pre-visit prep / usual care
Participants randomized to pre-visit prep will receive a study packet with educational materials and a question prompt list. These participants will be instructed to review the materials, discuss them with family members if desired, use the question prompt list to select questions they would like to ask at clinic visit 1, and bring the list to their clinic visit 1 appointment.~Participants will receive usual care.
Experimental: No prep / usual care + exome seq
Participants in the no pre-visit preparation arm will receive a mailed card reminding them about their upcoming clinic visit.~Participants will receive usual care and will be offered research exome sequencing.
No Intervention: No prep / usual care
Participants in the no pre-visit preparation arm will receive a mailed card reminding them about their upcoming clinic visit.~Participants will receive usual care.
Who are the authors of this trial?
Jonathan S Berg

This content was sourced from clinicaltrials.gov