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Clinical Decision Support for Genetic Disorders (SIGHT Trial)
Nashville, TN
N/A
Waitlist Available
Led By Douglas Ruderfer, PhD
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Must not have
Patients over 20 years of age or under 1 year of age.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to see if the SIGHT system can help doctors and patients talk about whether genetic testing is necessary. They will look at how well SIGHT can predict who needs testing, if it speeds
See full description
Who is the study for?
This trial is for pediatric patients aged between 1 and 20 years with a scheduled visit to VUMC's primary care. It aims to help those who might have undiagnosed genetic diseases by identifying if they need genetic testing.Check my eligibility
What is being tested?
The study tests the SIGHT system, which prompts healthcare providers to discuss the potential need for a chromosomal microarray test with patients. The goal is to see if this support system can shorten the time to testing and improve diagnosis rates.See study design
What are the potential side effects?
Since this intervention involves prompting discussions rather than medical treatments, there are no direct side effects like you'd expect from medication or surgery. However, it may impact decision-making in clinical settings.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am either older than 20 years or younger than 1 year.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Diagnoses in the intervention arm compared to the control arm
Secondary study objectives
Abnormal CMA
Diagnosis via any test (molecular confirmation)
Rate of genetic testing
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 Intervention
SIGHT predictions will be generated prior to a scheduled encounter in one of the participating study clinics. Patients with a SIGHT probability above a predefined risk level (0.30 predicted risk based on validation and prior chart review by a genetic counselor, Morley et al, 2021 below) will prompt randomization to the standard care or SIGHT-guided intervention arm.
For patients randomized to the SIGHT-guided intervention arm, the clinician responsible for care in that encounter (determined in the usual course of care) will receive a message for that patient and details as to the contributing clinical features that led to the high probability.
The message will include a recommendation, but providers will have full discretion to offer genetic testing or refer to genetics providers. The management of screening will follow standard of care at VUMC.
Group II: ComparatorActive Control1 Intervention
All remaining patients will be the comparator arm which will be standard of care as to avoid ethical situations of withholding potentially important care.
Find a Location
Closest Location:Vanderbilt University Medical· Nashville, TN· 620 miles
Who is running the clinical trial?
Vanderbilt University Medical CenterLead Sponsor
919 Previous Clinical Trials
937,746 Total Patients Enrolled
2 Trials studying Pediatrics
17,444 Patients Enrolled for Pediatrics
Douglas Ruderfer, PhDPrincipal InvestigatorVanderbilt University Medical Center