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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: Completed Early Phase 1 study, sponsored by Geisinger Clinic.
NCT03832985 is a Early Phase 1 study that has completed, run by Geisinger Clinic. The registered enrollment target is 162 participants, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (206% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The HADS questionnaire is a 14-item scale comprised of seven questions for anxiety and seven questions for depression. Each item is scored from 0-3. The total scoring is as follows: 8-10 = Mild, 11-14 = Moderate, 15-21 = Severe. Scoring for anxiety and depression are to be completed separately. For both scales, a total score of less than 7 indicates non-cases. Total range is 0 (lowest anxiety) - 21 (most severe anxiety).
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 |
What the finished NCT03832985 record still lists
NCT03832985 is an interventional study that assigns participants to a tested intervention. The registered 162 participants enrollment target is mid-sized for trials with a published cap, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (206% higher).
The record links to 0 conditions, and to 5 interventions - of which Child(ren) receive an adult-onset result is the first listed.
NCT03832985 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03832985's enrollment target sits among peer trials
162 83rd of 2000 higher than 1,917 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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