5-year Study to Track Clinical Application of DecisionDx-Melanoma Gene Expression Profile Assay Results

Castle Biosciences Incorporated301 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

301

Conditions

Cutaneous Melanoma

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

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

Locations (3)

Outcomes

Primary Outcomes

Adjusted surveillance regimen

* Relaxed surveillance for the low risk group; * Increased vigilance for early detection in the high risk group.

Time frame: upon receipt DecisionDX-Melanoma results received and every 6 months thereafter

Secondary Outcomes

Referral for sentinel lymph node interrogation in the high risk group in thin melanomas.

referral to SLNB in HR melanoma

Time frame: Upon receipt DecisionDx-Melanoma results