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NCT03832985 · ClinicalTrials.gov registry record · Early Phase 1
Pediatric Reporting of Adult-Onset Genomic Results
A Early Phase 1 study, sponsored by Geisinger Clinic.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 162
- Enrollment target
NCT03832985 is a Early Phase 1 study that has completed, run by Geisinger Clinic. The registered enrollment target is 162 participants.
The verdict
NCT03832985, a Early Phase 1 study, has completed, sponsored by Geisinger Clinic.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 162 participants
- Enrollment target
Study 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.
Interventions
- GENETIC Child(ren) receive an adult-onset result
- GENETIC Child(ren) received a pediatric-onset result
- GENETIC Control - Negative Result
- GENETIC Adolescents who received adult-onset result
- GENETIC Adolescents who received a pediatric-onset result
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 162 participants |
| Start Date | 2020-11-25 |
| Est. Completion | 2024-10-31 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03832985
The ClinicalTrials.gov registry entry for NCT03832985 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 162 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Geisinger Clinic, which has 107 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Child(ren) receive an adult-onset result is the first listed.
NCT03832985 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03832985 about?
NCT03832985 is a clinical study titled "Pediatric Reporting of Adult-Onset Genomic Results". 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...
What is the current status of trial NCT03832985?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 162 participants. The study started on 2020-11-25. Estimated completion is 2024-10-31.
What interventions are being tested in trial NCT03832985?
The interventions under investigation include: Child(ren) receive an adult-onset result (GENETIC), Child(ren) received a pediatric-onset result (GENETIC), Control - Negative Result (GENETIC), Adolescents who received adult-onset result (GENETIC), Adolescents who received a pediatric-onset result (GENETIC).
Who is sponsoring clinical trial NCT03832985?
This trial is sponsored by Geisinger Clinic, which has 107 total clinical trials registered on ClinicalTrials.gov.
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