An Open, 5-year Registry Study to Track Clinical Application of DecisionDx-Melanoma Gene Expression Profile Assay Results and Associated Patient Outcomes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 72
- Locations
- 4
- Primary Endpoint
- Adjusted surveillance regimen
Study Overview
Brief Summary
The EXPAND Registry Study follows patients with cutaneous melanoma who have had the DecisionDx-Melanoma gene expression assay performed as part of their clinical care. Data will be collected through review of medical records from clinical visits with physician.
The purpose is to document the clinical application of results obtained from the DecisionDx- Melanoma multi-gene assay and to track outcomes of patients for whom DecisionDx-Melanoma testing has been completed. Additionally the study will assess the health economic impact of DecisionDx-Melanoma testing as it relates to the Melanoma population.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 16 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients diagnosed with melanoma and determined, by their physician, to be appropriate for DecisionDx-Melanoma testing and who have successful results available to the investigator are eligible for registration
- •Patients enrolled should be reasonably able to follow-up with the enrolling physician at regular intervals for assessment of outcome data.
- •16 Years and older
Exclusion Criteria
- •Less than 16 Years of age
Outcomes
Primary Outcomes
Adjusted surveillance regimen
Time Frame: upon receipt DecisionDX-Melanoma results received and every 6 months thereafter
* Relaxed surveillance for the low risk group; * Increased vigilance for early detection in the high risk group.
Secondary Outcomes
- Referral for sentinel lymph node interrogation in the high risk group in thin melanomas.(Upon receipt DecisionDx-Melanoma results)