Rapid Whole Genome Sequencing Study

Part of paid clinical trials in San Diego, California.

Sponsor
Rady Pediatric Genomics & Systems Medicine Institute
Study ID
NCT03385876
Status
Enrolling By Invitation

Conditions

  • Genetic Diseases
  • Genetic Syndrome

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Accepted

Interventions

  • Genomic sequencing and molecular diagnostic results, if any — GENETIC
    Samples will be stored in the pediatric genomic biorepository. A subset of samples will undergo genetic/genomic analysis.

Study Details

Rapid Whole Genome Sequencing (rWGS) has proven to provide much faster diagnoses than traditional clinical testing, including clinical Whole Exome Sequencing (WES) and standard Whole Genome Sequencing (WGS). This collaborative study seeks to provide rWGS as a research test to additional pediatric hospitals nationwide to assist in the rapid diagnosis of acutely ill children suspected of a genetic condition. The study will examine diagnosis rates, changes in clinical care as a result of a genetic diagnosis, and health economics including potential cost-effectiveness of rWGS. This study will also serve as a biorepository for future research on samples and data generated from genomic sequencing.

Key Dates

Start date
Aug 29, 2017
Status verified
Dec 2021
Primary completion
Dec 31, 2050
Completion
Dec 31, 2050

Study Design

Enrollment
100,000 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Enrollees
    Enrollment of healthy and affected subjects to collect samples and data for a pediatric genomic biorepository. Data includes genomic sequencing and resultant molecular diagnostic results, if any.

Primary Outcome Measure

Number of samples enrolled per year [ Time Frame: Yearly through study completion estimated to be 40 years. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Rady Children's Institute for Genomic MedicineSan DiegoCalifornia92123-

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