Pediatric Reporting of Adult-Onset Genomic Results

Completed · Early Phase 1

Conditions studied: Hereditary Breast and Ovarian Cancer Syndrome, Lynch Syndrome, Familial Hypercholesterolemia

In brief

The Investigators will conduct a longitudinal, mixed-methods cohort study to assess primary and secondary psychosocial outcomes among MyCode adolescent participants and their parents, and health behaviors of children who received 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 children's 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.

Key facts

Study ID

NCT03832985

Run by

Geisinger Clinic

People needed

162

Starts

2020-11-25

Expected to finish

2024-10-31

Last updated by the study team

2026-04-09

Who can join

Age: any. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Any pediatric MyCode participant (ages 0-17) OR
• Parent of a pediatric MyCode participant who has given assent to participate in this study.

You may not qualify if…

• Individuals who have already had genetic counseling for any of the actionable target conditions as part of their routine clinical care.
• Individuals who have already had genetic counseling for any of the actionable target conditions through their participation in another research study.

Where it is running

• Geisinger — Danville, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.