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

Completed

• Conditions: Uveal Melanoma

• Registration Number: NCT02376920
• Lead Sponsor: Castle Biosciences Incorporated

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2015-02-13
• Study First Submitted QC: 2015-03-02
• Study First Posted: 2015-03-03
• Primary Completion: 2022-04
• Study Completion: 2022-04
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-13
• Last Update Posted: 2022-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 93

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
documentation of clinical application of results obtained from DecisionDx-UM multi-gene assay	Approximately 3-6 weeks after biopsy of uveal tumor	Physician treatment plan with regards to surveillance regimen as well as treatment referral pattern
Time to metastasis	Patients followed for up to 10 years, measurement for metastatic event performed at 6 month intervals

Secondary Outcome Measures

Name	Time	Method
changes in health care costs	Patients followed for up to 10 years at 6 month intervals	review of health care testing (imaging, laboratory testing) to determine changes in health care costs resulting from DecisionDx-UM testing