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

Terminated

• Conditions: Cutaneous Melanoma

• Registration Number: NCT02355574
• Lead Sponsor: Castle Biosciences Incorporated

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-12-18
• Study First Submitted QC: 2015-02-03
• Study First Posted: 2015-02-04
• Primary Completion: 2021-02
• Study Completion: 2021-07
• Status Verified: 2021-09
• Last Update Submitted: 2021-10-01
• Last Update Posted: 2021-10-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 301

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adjusted surveillance regimen	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.

Secondary Outcome Measures

Name	Time	Method
Referral for sentinel lymph node interrogation in the high risk group in thin melanomas.	Upon receipt DecisionDx-Melanoma results	referral to SLNB in HR melanoma

Trial Locations

Locations (3)

University of Louisville; 🇺🇸 Louisville, Kentucky, United States

Saint Louis University; 🇺🇸 Saint Louis, Missouri, United States

Northside Hospital; 🇺🇸 Atlanta, Georgia, United States