N/A
N=115,484
Early Detection of GEnetic Risk (EDGE)
Genetic Predisposition
Bottom Line
View on ClinicalTrials.gov: NCT04746794 ↗Enrolled (actual)
115,484
Serious AEs
—
Results posted
Oct 2024
Primary outcome: Primary: Rates of Screening — 9892; 3813 Participants — p=0.0074
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Population-level screening (Behavioral)
- Age
- Adult, Older Adult · 25+ yrs
- Sex
- All
- Sponsor
- University of Washington
- Primary completion
- May 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rates of Screening |
9892; 3813 | 0.0074 sig |
| PRIMARY Rates of Testing |
757; 717 | <0.0001 sig |
| SECONDARY Total Cost of Each Engagement Strategy |
640,776; 697,116; 648,395; 698,350 | — |
| SECONDARY Incremental Cost When Comparing Two Engagement Strategies |
56,340; 49,955 | — |
| SECONDARY Rates of Screening and Testing at Healthcare System A |
4,327; 1,370; 233; 254 | — |
| SECONDARY Incremental Patients Screened; Incremental Patients Tested |
-8,105; 404 | — |
| SECONDARY Incremental Cost-effectiveness Ratio (ICER) Per Patient Screened; Incremental Cost-effectiveness Ratio Per Patient Tested |
-7; -6; 140; 124 | — |
Summary
The study intervention involves having patients complete a familial cancer risk assessment survey. Those who are found to be at high risk will be offered genetic testing for a panel of hereditary cancers. A "previvor" plan will be created to assist patients and their providers in completing the appropriate follow-up for those with a mutation identified.
Eligibility Criteria
Inclusion Criteria for Patients:
- Age 25 or older
- An active patient at a participating clinic (had at least one visit in the past 12 months)
- Comfortable reading and writing in English
Exclusion Criteria
- Those who do not meet inclusion criteria.
Data sourced from ClinicalTrials.gov (NCT04746794). 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.