Five Year Study to Track Use of DecisionDX-Melanoma Test in Patients With Cutaneous Melanoma and Associated Patient Outcomes

Castle Biosciences Incorporated72 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

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 (4)

Sutter Health

Santa Rosa, California, United States

Elizabeth Liotta Dermatology

Frederick, Maryland, United States

University of Nevada

Las Vegas, Nevada, United States

South Carolina Skin Care Center

Greenville, South Carolina, United States

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.

Time frame: Upon receipt DecisionDx-Melanoma results