5-year Study to Track Clinical Application of DecisionDx-Melanoma Gene Expression Profile Assay Results
This trial is active, not recruiting.
|Sponsor||Castle Biosciences Incorporated|
|Start date||March 2014|
|End date||February 2024|
|Trial size||1672 participants|
|Trial identifier||NCT02355574, INTEGRATE_1_Protocol|
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|
Adjusted surveillance regimen
time frame: upon receipt DecisionDX-Melanoma results received and every 6 months thereafter
Referral for sentinel lymph node interrogation in the high risk group in thin melanomas.
time frame: Upon receipt DecisionDx-Melanoma results
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
|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|
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