5 Year Registry Study to Track Clinical Application of DecisionDx-UM Assay Results and Associated Patient Outcomes

Castle Biosciences Incorporated93 enrolled

Overview

Uveal Melanoma is a rare cancer with approximately 3,000 cases diagnosed in the US every year. Nearly half of these experience spread of their cancer outside the eye. The DecisionDx-UM gene expression test classifies an individual's tumor as low risk (class 1) or high risk (class 2) of spreading. This study is being done to collect information about how physicians are using the DecisionDx-UM results to design individual treatment plans. It will also track outcomes or the uveal melanoma population that received DecisionDx-UM testing.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Uveal Melanoma

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with a diagnosis of Uveal Melanoma * Patients whose physician deems them appropriate for DecisionDx-UM testing * Patients reasonably able to follow up with enrolling physician at regular intervals for assessment of outcome data Exclusion Criteria: * Patients with any other form of cancer

Outcomes

Primary Outcomes

documentation of clinical application of results obtained from DecisionDx-UM multi-gene assay

Physician treatment plan with regards to surveillance regimen as well as treatment referral pattern

Time frame: Approximately 3-6 weeks after biopsy of uveal tumor

Secondary Outcomes

changes in health care costs

review of health care testing (imaging, laboratory testing) to determine changes in health care costs resulting from DecisionDx-UM testing

Time frame: Patients followed for up to 10 years at 6 month intervals