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

Castle Biosciences

Status: Terminated

Conditions: Cutaneous Melanoma

Study type: Observational

Funder types: Industry

Identifiers

NCT02355574

INTEGRATE_1_Protocol

Details and patient eligibility

About

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.

Enrollment: 301 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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