Rady Children's Institute Genomic Biorepository

Part of paid clinical trials in San Diego, California.

Sponsor
Rady Pediatric Genomics & Systems Medicine Institute
Study ID
NCT02917460
Status
Recruiting
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Conditions

  • Genetic Diseases

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

Rady Children's Institute for Genomic Medicine (RCI) will collect biological samples (such as blood), derived genomic sequences (from DNA and RNA), and clinical features in a Biorepository as a standardized resource for future research studies. The purpose of the Genomic Institute Biorepository is to provide consented samples and data for basic and clinical research related to the genomic cause and treatment of childhood disease, and, in the future, as reference (Quality Control) data to improve the ability to make clinical diagnoses or clinical decisions. In addition, the Biorepository will provide a mechanism for making a diagnosis of a genetic disease. That is, once genomic sequences have been derived from biological samples, they will be immediately analyzed. If a genetic disease is identified that appears to explain an affected child's clinical features, then those results will be confirmed by the medically accepted standard, and placed in the electronic health record.

Key Dates

Start date
Jul 31, 2016
Status verified
Dec 2022
Primary completion
Dec 31, 2050
Completion
Dec 31, 2050

Study Design

Enrollment
102,000 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Rady Pediatric Genomics & Systems Medicine InstituteSan DiegoCalifornia92123
Dominic Baun, MBS
[email protected]
858-576-1700
Lauren Olsen, MSN
[email protected]
858-576-1700

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