Clinical Trial: Five Year Study to Track Use of DecisionDX-Melanoma Test in Patients With Cutaneous Melanoma and Associated Patient Outcomes
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational [Patient Registry]
Official Title: An Open, 5-year Registry Study to Track Clinical Application of DecisionDx-Melanoma Gene Expression Profile Assay Results and Associated Patient Outcomes
Brief Summary:
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.
Detailed Summary:
Sponsor: Castle Biosciences Incorporated
Current Primary Outcome: Adjusted surveillance regimen [ Time Frame: 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.
Original Primary Outcome: Same as current
Current Secondary Outcome: Referral for sentinel lymph node interrogation in the high risk group in thin melanomas. [ Time Frame: Upon receipt DecisionDx-Melanoma results ]
Original Secondary Outcome: Same as current
Information By: Castle Biosciences Incorporated
Dates:
Date Received: December 18, 2014
Date Started: March 2014
Date Completion: February 2024
Last Updated: February 23, 2017
Last Verified: February 2017
