Reporting Adult-Onset Genomic Results to Pediatric Biobank Participants and Parents

Status: Completed
Location: See location...
Intervention Type: Genetic
Study Type: Interventional
Study Phase: Early Phase 1
SUMMARY

The Investigators will conduct a longitudinal, mixed-methods cohort study to assess primary and secondary psychosocial outcomes among 705 MyCode pediatric participants and their parents, and health behaviors of parents whose children receive an adult- or pediatric-onset genomic result. Data will be gathered via quantitative surveys using validated measures of distress, family functioning, quality of life, body image, perceived cancer/heart disease risk, genetic counseling satisfaction, genomics knowledge, and adjustment to genetic information; qualitative interviews with adolescents and parents; and electronic health records review of parents' cascade testing uptake and initiation of risk reduction behaviors. The investigators will also conduct empirical and theoretical legal research to examine the loss of chance doctrine and its applicability to genomic research.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: t
View:

• Any pediatric MyCode participant (ages 0-17) OR

• Parent of a pediatric MyCode participant who has given assent to participate in this study.

Locations
United States
Pennsylvania
Geisinger
Danville
Time Frame
Start Date: 2020-11-25
Completion Date: 2024-10-31
Participants
Target number of participants: 427
Treatments
Experimental: Receive an adult-onset result
Compare change in psychosocial outcomes and health behaviors of those with a pathogenic variant in a gene associated with adult onset of disease.
Experimental: Receive a pediatric-onset result
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.
Active_comparator: Control - No result
Compare change in psychosocial outcomes and health behaviors of those without a genomic result.
Authors
Adam H Buchanan
Sponsors
Collaborators: National Human Genome Research Institute (NHGRI)
Leads: Geisinger Clinic

This content was sourced from clinicaltrials.gov