Cutaneous Melanoma
Conditions
Keywords
melanoma, cutaneous melanoma, DecisionDx-Melanoma
Brief summary
The INTEGRATE Registry Study follows patients with cutaneous melanoma who have had the DecisionDx-Melanoma gene expression assay performed. 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.
Interventions
None listed
Sponsors
Castle Biosciences Incorporated
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adjusted surveillance regimen | 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
| Measure | Time frame | Description |
|---|---|---|
| Referral for sentinel lymph node interrogation in the high risk group in thin melanomas. | Upon receipt DecisionDx-Melanoma results | referral to SLNB in HR melanoma |
Other
| Measure | Time frame | Description |
|---|---|---|
| Early referral to medical oncologist for high risk patients. | Upon Receipt DecisionDx-Melanoma results | referral |
Countries
United States
Outcome results
None listed