Clinical trial · Interventional
Early Detection of GEnetic Risk (EDGE)
Implementing the Moon: Getting Genomic Testing to the Public
NCT04746794CI-TRIAL-00081411completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Genetic Predisposition | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Population-level screening | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Point of Care
- description
- For clinics in the point of care (POC) arm, patients will be approached at the time they come in to the clinic for a routine visit with their primary care provider. We will screen patients for familial cancer risk using electronic tablets in the waiting room or, in the case of a telehealth visit, through telephone contact before the visit. Patients identified as high risk will be offered genetic testing for a panel of hereditary cancers.
- interventionNames
- Behavioral: Population-level screening
- type
- EXPERIMENTAL
- label
- Direct Patient Engagement
- description
- For clinics in the direct patient engagement (DPE) arm, patients will be identified by reviewing clinic records to create an "active" patient list (i.e., those who have had a visit in the past year). We will contact patients by postal mail and email to provide a link to the online risk screening tool. The patient outreach is not tied to a specific visit and the online screening can be completed at any time. Patients identified as high risk will be offered genetic testing for a panel of hereditary cancers.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 25 Years
Show eligibility criteria text
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.
References
Publications (2)
- DERIVEDDevine B, Aalbers SE, Chan H, Jiang S, Dusic EJ, Knerr S, Harris HM, Wang C, Norquist BM, Riemann LA, Brant JM, Shirts BH, Swisher EM. Cost-effectiveness of primary care-based risk assessment and hereditary cancer genetic testing. BMC Prim Care. 2025 Dec 22;27(1):33. doi: 10.1186/s12875-025-03137-w. PMID 41423596
- DERIVEDSwisher EM, Harris HM, Knerr S, Theoryn TN, Norquist BM, Brant J, Shirts BH, Beers F, Cameron D, Dusic EJ, Riemann LA, Devine B, Raff ML, Kadel R, Cabral HJ, Wang C. Strategies to Assess Risk for Hereditary Cancer in Primary Care Clinics: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2025 Mar 3;8(3):e250185. doi: 10.1001/jamanetworkopen.2025.0185. PMID 40053353