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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02355574
Other study ID # INTEGRATE_1_Protocol
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date June 2014
Est. completion date July 2021

Study information

Verified date September 2021
Source Castle Biosciences Incorporated
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 301
Est. completion date July 2021
Est. primary completion date February 2021
Accepts healthy volunteers No
Gender All
Age group 16 Years and older
Eligibility 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


Related Conditions & MeSH terms


Locations

Country Name City State
United States Northside Hospital Atlanta Georgia
United States University of Louisville Louisville Kentucky
United States Saint Louis University Saint Louis Missouri

Sponsors (1)

Lead Sponsor Collaborator
Castle Biosciences Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Early referral to medical oncologist for high risk patients. referral Upon Receipt DecisionDx-Melanoma results
Primary Adjusted surveillance regimen Relaxed surveillance for the low risk group;
Increased vigilance for early detection in the high risk group.
upon receipt DecisionDX-Melanoma results received and every 6 months thereafter
Secondary Referral for sentinel lymph node interrogation in the high risk group in thin melanomas. referral to SLNB in HR melanoma Upon receipt DecisionDx-Melanoma results
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