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Genetic Testing

Reporting of Adult-Onset Genomic Results in Pediatric Patients

Phase < 1
Waitlist Available
Led By Adam H Buchanan, MS, MPH, CGC
Research Sponsored by Geisinger Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Any pediatric MyCode participant (ages 0-17)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1, 6, &12 months post-disclosure
Awards & highlights

Summary

This trial will assess the psychological effects on children and their parents who receive genomic results, as well as health behaviors of parents whose children receive an adult- or pediatric-onset genomic result.

Who is the study for?
This trial is for children (ages 0-17) enrolled in the MyCode study and their parents. It's not open to those who've already had genetic counseling for conditions like colorectal cancer, high cholesterol, or breast and ovarian cancer syndrome through other studies or routine care.Check my eligibility
What is being tested?
The study looks at how getting genomic results about diseases that could affect them as adults impacts kids and their families. Some will get info on adult-onset conditions, others on pediatric-onset ones, while a control group won't receive any results.See study design
What are the potential side effects?
There are no direct medical side effects since this isn't a drug trial. However, receiving genetic information may cause psychological distress or impact family dynamics and health behaviors.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am under 18 and part of the MyCode study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1, 6, &12 months post-disclosure
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1, 6, &12 months post-disclosure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Health-Related Quality of Life (HRQOL)
Initiation of risk reduction behavior
The General Functioning 12-item subscale (GF12) of The McMaster Family Assessment Device (FAD)
+2 more
Secondary outcome measures
Body Image instrument
Children's Revised Impact of Events scale
Decision Regret scale
+4 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Receive an adult-onset resultExperimental Treatment1 Intervention
Compare change in psychosocial outcomes and health behaviors of those with a pathogenic variant in a gene associated with adult onset of disease.
Group II: Receive a pediatric-onset resultExperimental Treatment1 Intervention
Compare change in psychosocial outcomes and health behaviors of those with a pathogenic variant in a gene associated with pediatric onset of disease or with risk reduction interventions that begin in childhood.
Group III: Control - No resultActive Control1 Intervention
Compare change in psychosocial outcomes and health behaviors of those without a genomic result.

Find a Location

Who is running the clinical trial?

National Human Genome Research Institute (NHGRI)NIH
263 Previous Clinical Trials
283,722 Total Patients Enrolled
Geisinger ClinicLead Sponsor
149 Previous Clinical Trials
1,883,066 Total Patients Enrolled
Adam H Buchanan, MS, MPH, CGCPrincipal InvestigatorGeisinger - Genomic Medicine Institute

Media Library

Control - No Result (Genetic Testing) Clinical Trial Eligibility Overview. Trial Name: NCT03832985 — Phase < 1
High Cholesterol Research Study Groups: Receive an adult-onset result, Receive a pediatric-onset result, Control - No result
High Cholesterol Clinical Trial 2023: Control - No Result Highlights & Side Effects. Trial Name: NCT03832985 — Phase < 1
Control - No Result (Genetic Testing) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03832985 — Phase < 1
~91 spots leftby Jul 2025
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