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Genomic Sequencing
Genomic Sequencing for Genetic Disorders (rWGS Trial)
N/A
Waitlist Available
Led By David Dimmock, MD
Research Sponsored by Rady Pediatric Genomics & Systems Medicine Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
A symptomatic patient is characterized as a patient whose treating physician has identified phenotypic features and/or signs of illness potentially attributable to a genetic disorder (also referred to as 'Affected' or 'Proband')
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion estimated to be 40 years.
Awards & highlights
rWGS Trial Summary
This trial will help researchers learn if rapid whole genome sequencing can provide faster diagnoses than traditional clinical testing for children with genetic conditions.
Who is the study for?
This trial is for acutely ill children suspected of having a genetic condition, with no restrictions on age, gender, race, or health. Preference is given to those under 4 months old and where diagnosis could change treatment. It includes symptomatic patients and their biological family members.Check my eligibility
What is being tested?
The study tests Rapid Whole Genome Sequencing (rWGS) as a faster diagnostic tool compared to traditional methods for genetic conditions in children. It aims to assess diagnosis rates, impact on clinical care, and potential cost-effectiveness.See study design
What are the potential side effects?
Since the intervention involves genomic sequencing without direct medical treatments or drugs being administered, there are typically no physical side effects associated with the procedure itself.
rWGS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My doctor says my symptoms may be due to a genetic disorder.
rWGS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion estimated to be 40 years.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion estimated to be 40 years.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of samples enrolled per year
Secondary outcome measures
Comparing diagnostic rates between singleton and trio analysis
Proportion of children in which human phenotype ontology (HPO) terms accurately predict molecular diagnosis
Proportion of children receiving molecular diagnoses
+2 morerWGS Trial Design
1Treatment groups
Experimental Treatment
Group I: EnrolleesExperimental Treatment1 Intervention
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.
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Who is running the clinical trial?
Rady Pediatric Genomics & Systems Medicine InstituteLead Sponsor
8 Previous Clinical Trials
113,853 Total Patients Enrolled
David Dimmock, MDPrincipal InvestigatorRady Pediatric Genomics & Systems Medicine Institute
Stephen KingsmoreStudy DirectorRady Pediatric Genomics & Systems Medicine Institute
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My doctor says my symptoms may be due to a genetic disorder.I meet the study's inclusive criteria regarding age, gender, race, and health.My child is under 4 months old, very sick, and might have a genetic condition.My condition is better suited for traditional genetic tests.My condition does not strongly suggest a genetic cause.I am experiencing symptoms, a biological family member of someone with the condition, or a control individual.
Research Study Groups:
This trial has the following groups:- Group 1: Enrollees
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this trial still accepting participants?
"Evidently, this medical trial is not actively enrolling patients at present. It first appeared on clinicaltrials.gov in August of 2017 and was last modified on December 7th 2021. Conversely, 46 other studies are presently looking for participants to contribute data."
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