CompletedEarly Phase 1

Pediatric Reporting of Adult-Onset Genomic Results

United States162 participantsStarted 2020-11-25

Plain-language summary

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.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale

Timeframe: Baseline

The Hospital Anxiety and Depression Scale (HADS) - Depression Subscale

Timeframe: Baseline

The General Functioning 12-item Subscale (GF12) of The McMaster Family Assessment Device (FAD)

Timeframe: Baseline

Health-Related Quality of Life (HRQOL)

Timeframe: Baseline

Initiation of Risk Reduction Behavior

Timeframe: 6+ months post-disclosure to pediatric proband

The Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale

Timeframe: 1-month post-disclosure

The Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale

Timeframe: 6-month post-disclosure

Trial details

NCT IDNCT03832985

SponsorGeisinger Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-10-31

Results submitted2025-11-04

View on ClinicalTrials.gov More Hereditary Breast and Ovarian Cancer Syndrome trials

Plain-language summary

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

The Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale

Timeframe: Baseline

The Hospital Anxiety and Depression Scale (HADS) - Depression Subscale

Timeframe: Baseline

The General Functioning 12-item Subscale (GF12) of The McMaster Family Assessment Device (FAD)

Timeframe: Baseline

Health-Related Quality of Life (HRQOL)

Timeframe: Baseline

Initiation of Risk Reduction Behavior

Timeframe: 6+ months post-disclosure to pediatric proband

The Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale

Timeframe: 1-month post-disclosure

The Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale

Timeframe: 6-month post-disclosure