Overview

This trial is active, not recruiting.

Condition cutaneous melanoma
Sponsor Castle Biosciences Incorporated
Start date March 2014
End date February 2024
Trial size 1672 participants
Trial identifier NCT02355574, INTEGRATE_1_Protocol

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Measure
Adjusted surveillance regimen
time frame: upon receipt DecisionDX-Melanoma results received and every 6 months thereafter

Secondary Outcomes

Measure
Referral for sentinel lymph node interrogation in the high risk group in thin melanomas.
time frame: Upon receipt DecisionDx-Melanoma results

Eligibility Criteria

Male or female participants at least 16 years old.

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

Additional Information

Official title An Ongoing, 5-year Post Market Study to Track Clinical Application of DecisionDx-Melanoma Gene Expression Profile (GEP) Assay Results and the Impact on Patient Outcomes and Health Economics
Principal investigator Robert Cook, PhD
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Castle Biosciences Incorporated.
Location data was received from the National Cancer Institute and was last updated in January 2016.