N/A
Completed N=967
Cancer Health Assessments Reaching Many
Hereditary Cancer Syndrome
Source: ClinicalTrials.gov NCT03426878 ↗
Enrolled (actual)
967
Serious AEs
—
Results posted
Sep 2025
Primary outcomePrimary: Positive Findings for Hereditary Cancer Syndromes — 28; 8; 4; 787 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Positive Findings for Hereditary Cancer Syndromes |
28; 8; 4; 787 | — |
| SECONDARY Positive Findings for Other Medically Actionable Genetic Conditions |
9 | — |
| SECONDARY Positive Findings for a Selected List of Carrier Conditions |
55 | — |
| SECONDARY Number of Participants With Healthcare Utilization Measured Via Electronic Medical Record (EMR) Data |
6; 153 | — |
| SECONDARY Participant Understanding of Recommended Care |
— | — |
| SECONDARY Participant Understanding of Genetic Test Results |
4.38; 4.42 | — |
| SECONDARY Participant Satisfaction of Genetic Counseling |
4.68; 4.70; 1.82; 1.83; 4.29; 4.37 | — |
| SECONDARY Family Communication |
466 | — |
| SECONDARY Personal Utility of Genomic Sequencing (Qualitative Interview Only) |
— | — |
Eligibility Criteria
Inclusion Criteria
- Kaiser Permanente Northwest or Denver Health patient
- Screens as high risk for a hereditary cancer syndrome via the risk assessment tool algorithms OR have unknown family history on either their mother or father's side of the family (or both)
- No known prior testing for familial mutations predisposing them to Lynch syndrome or hereditary breast and ovarian cancer
- English or Spanish speaker
Exclusion Criteria
- Participant self-reported prior testing for Lynch syndrome (LS) or Hereditary Breast and Ovarian Cancer (HBOC) syndrome or identified as having previous comprehensive testing via Kaiser Permanente data files
- Not an English or Spanish speaker
- Unable to provide informed consent
- Don't want results placed in their medical record
Data sourced from ClinicalTrials.gov (NCT03426878). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.