NCT04746794

Early Detection of GEnetic Risk (EDGE)

Completed NA Results posted Last updated 9 October 2024

What this trial tests

NA trial testing Population-level screening in Genetic Predisposition in 20,184 participants. Completed in 1 June 2023.

Timeline

25 September 2020

Primary endpoint
31 May 2023

1 June 2023

Quick facts

Lead sponsor	University of Washington
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	20,184
Start date	25 September 2020
Primary completion	31 May 2023
Estimated completion	1 June 2023
Sites	2 locations across United States

Drugs / interventions tested

• Population-level screening

Conditions studied

• Genetic Predisposition — all drugs for Genetic Predisposition →

Sponsor

University of Washington

Who can join

25 and older, any sex, with Genetic Predisposition. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Rates of Screening Primary · 1 year

Fraction of the active clinic patient population that completed screening

Group	Value	95% CI
Point of Care	9892
Direct Patient Engagement	3813

Rates of Testing Primary · 1 year

Fraction of the active clinic patient population that completed genetic testing.

Group	Value	95% CI
Point of Care	757
Direct Patient Engagement	717

Total Cost of Each Engagement Strategy Secondary · 2 years

This outcome is the total costs for each engagement strategy, scaled to a healthcare system of 100,000 patients. The total costs from the health-system perspective is the sum of program costs and staff costs over 2 years, in U.S. dollars. The cost from the limited societal perspective includes patient costs in addition to health-system costs. The total costs will be used in the incremental cost calculation below.

Cost from health-system perspective

Group	Value	95% CI
Point of Care	640,776
Direct Patient Engagement	697,116

Cost from limited societal perspective (includes patient costs)

Group	Value	95% CI
Point of Care	648,395
Direct Patient Engagement	698,350

Incremental Cost When Comparing Two Engagement Strategies Secondary · 2 years

This outcome is the comparative (incremental) cost of two different engagement strategies for population-based risk assessment for hereditary cancer genetic screening and testing in primary care. The total costs for each arm are presented in outcome 3 above. The incremental cost is the difference in total costs when comparing the DPE arm to the POC arm (DPE minus POC).

Incremental cost from health-system perspective

Group	Value	95% CI
Direct Patient Engagement Compared to Point of Care	56,340

Incremental cost from limited societal perspective (includes patient costs)

Group	Value	95% CI
Direct Patient Engagement Compared to Point of Care	49,955

Rates of Screening and Testing at Healthcare System A Secondary · 2 years

The table displays the percentages (i.e., proportions) of screening and testing that occurred in the study. The number of patients screened and the number tested are listed as well, but as the denominators differ, the results for Outcome 6 will be based on scaling the proportions to a theoretical healthcare system with 100,000 patients. This information will then be used along with the incremental costs for a healthcare system with 100,000 patients (Outcome 4) to determine the incremental cost-effectiveness ratios (ICERs) presented in Outcome 7.

Patients screened

Group	Value	95% CI
Point of Care	4,327
Direct Patient Engagement	1,370

Patients tested

Group	Value	95% CI
Point of Care	233
Direct Patient Engagement	254

Incremental Patients Screened; Incremental Patients Tested Secondary · 2 years

This outcome is the comparative (incremental) difference between the two different engagement strategies in screening and testing outcomes. The total patients screened and tested for each arm are presented in outcome 5 above. The proportions for these outcomes were then scaled to a healthcare system of 100,000 patients and the incremental difference was calculated by comparing the DPE arm to the POC arm (DPE minus POC). Scaling the numbers to a healthcare system of 100,000 patients is necessary for this component to be compatible with the costs for a healthcare system of 100,000 patients given

Incremental patients screened

Group	Value	95% CI
Direct Patient Engagement Compared to Point of Care	-8,105

Incremental patients tested

Group	Value	95% CI
Direct Patient Engagement Compared to Point of Care	404

Incremental Cost-effectiveness Ratio (ICER) Per Patient Screened; Incremental Cost-effectiveness Ratio Per Patient Tested Secondary · 2 years

This outcome is the Incremental Cost-effectiveness Ratio (ICER). The ICER estimates how much the DPE strategy costs, relative to the POC strategy (DPE minus POC), to improve the outcome measure by 1 unit (in this case one additional patient screened or one additional patient tested). The ICER is calculated by using the difference in costs (outcome 4) divided by the difference in outcome (outcome 6). When the numerator is positive and the denominator is negative (as it is for screening), general practice is to state the second strategy (DPE in this case) was "dominated" by the first strategy (t

ICER per additional patient screened from health-system perspective

Group	Value	95% CI
Direct Patient Engagement Compared to Point of Care	-7

ICER per additional patient screened from limited societal perspective

Group	Value	95% CI
Direct Patient Engagement Compared to Point of Care	-6

ICER per additional patient tested from health-system perspective

Group	Value	95% CI
Direct Patient Engagement Compared to Point of Care	140

ICER per additional patient tested from limited societal perspective

Group	Value	95% CI
Direct Patient Engagement Compared to Point of Care	124

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Barriers, interventions, and recommendations: Improving the genetic testing landscape.
   Dusic EJ, Theoryn T, Wang C, Swisher EM, et al · · 2022 · cited 63× · PMID 36386046 · DOI 10.3389/fdgth.2022.961128
2. Strategies to Assess Risk for Hereditary Cancer in Primary Care Clinics: A Cluster Randomized Clinical Trial.
   Swisher EM, Harris HM, Knerr S, Theoryn TN, et al · · 2025 · cited 7× · PMID 40053353 · DOI 10.1001/jamanetworkopen.2025.0185
3. Cost-effectiveness of primary care-based risk assessment and hereditary cancer genetic testing.
   Devine B, Aalbers SE, Chan H, Jiang S, et al · · 2025 · PMID 41423596 · DOI 10.1186/s12875-025-03137-w