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NCT03426878 · ClinicalTrials.gov registry record · NA
Cancer Health Assessments Reaching Many
A NA study, sponsored by Kaiser Permanente.
- Completed
- Registry status
- NA
- Development phase
- 967
- Enrollment target
NCT03426878: Completed NA study, sponsored by Kaiser Permanente.
NCT03426878 is a NA study that has completed, run by Kaiser Permanente. The registered enrollment target is 967 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (31% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03426878, a NA study, has completed, sponsored by Kaiser Permanente.
- COMPLETED
- Registry status
- NA
- Development phase
- 967 participants
- Enrollment target
Study Summary
The CHARM (Cancer Health Assessment Reaching Many) study will assess the utility of clinical exome sequencing and how it affects care in diverse populations. The study population includes adults at risk for hereditary cancer syndromes. The primary objective is to implement a hereditary cancer risk assessment program in healthy 18-49 year-olds in primary care settings within a vertically integrated health delivery system (Kaiser Permanente) and a federal qualified health center (Denver Health). The investigators will assess clinical exome sequencing implementation and interpretation, as well as tailored interactions for low health literacy including a contextualized consent process, and a modified approach to results disclosure and genetic counseling. The investigators will also assess the clinical utility (healthcare utilization and adherence to recommended care) and personal utility of primary and additional results from clinical exome sequencing, and evaluate the ethical and policy implications of considering personal utility of genomic information decisions for health care coverage.
Primary Outcome
Number of people found to have a pathogenic (P) or likely pathogenic (LP) variant in one of the cancer genes associated with Lynch syndrome or hereditary breast and ovarian cancer
Interventions
- OTHER Modified genetic counseling
- OTHER Traditional genetic counseling
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 967 participants |
| Start Date | 2018-08-15 |
| Est. Completion | 2022-02-01 |
| Phase | NA |
What the finished NCT03426878 record still lists
NCT03426878 is an interventional study that assigns participants to a tested intervention. The registered 967 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (31% lower).
The record links to 0 conditions, and to 2 interventions - of which Modified genetic counseling is the first listed.
NCT03426878 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03426878 about?
NCT03426878 is a clinical study titled "Cancer Health Assessments Reaching Many". The CHARM (Cancer Health Assessment Reaching Many) study will assess the utility of clinical exome sequencing and how it affects care in diverse populations. The study population includes adults at risk for hereditary cancer syndromes. The primary objective is to implement a hereditary cancer risk ...
What is the current status of trial NCT03426878?
This trial is currently completed. It is a NA study. The enrollment target is 967 participants. The study started on 2018-08-15. Estimated completion is 2022-02-01.
What interventions are being tested in trial NCT03426878?
The interventions under investigation include: Modified genetic counseling (OTHER), Traditional genetic counseling (OTHER).
Who is sponsoring clinical trial NCT03426878?
This trial is sponsored by Kaiser Permanente, which has 294 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03426878's enrollment target sits among peer trials
967 123rd of 2000 higher than 1,878 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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