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

Cutaneous Melanoma Clinical Trial

— INTEGRATE  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02355574
• Other study ID #: INTEGRATE_1_Protocol
• Status: Terminated
• 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
• 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

Related Conditions & MeSH terms

• Cutaneous Melanoma
• Melanoma

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