- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02355587
Five Year Study to Track Use of DecisionDX-Melanoma Test in Patients With Cutaneous Melanoma and Associated Patient Outcomes (EXPAND)
An Open, 5-year Registry Study to Track Clinical Application of DecisionDx-Melanoma Gene Expression Profile Assay Results and Associated Patient Outcomes
The EXPAND Registry Study follows patients with cutaneous melanoma who have had the DecisionDx-Melanoma gene expression assay performed as part of their clinical care. 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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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California
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Santa Rosa, California, United States, 95403
- Sutter Health
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Maryland
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Frederick, Maryland, United States, 21702
- Elizabeth Liotta Dermatology
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Nevada
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Las Vegas, Nevada, United States, 89102
- University of Nevada
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South Carolina
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Greenville, South Carolina, United States, 29607
- South Carolina Skin Care Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adjusted surveillance regimen
Time Frame: upon receipt DecisionDX-Melanoma results received and every 6 months thereafter
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upon receipt DecisionDX-Melanoma results received and every 6 months thereafter
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Referral for sentinel lymph node interrogation in the high risk group in thin melanomas.
Time Frame: Upon receipt DecisionDx-Melanoma results
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Upon receipt DecisionDx-Melanoma results
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Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Early referral to medical oncologist for high risk patients.
Time Frame: Upon Receipt DecisionDx-Melanoma results
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Upon Receipt DecisionDx-Melanoma results
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Robert Cook, PhD, Castle Biosciences Inc.
Publications and helpful links
General Publications
- Whitman ED, Koshenkov VP, Gastman BR, Lewis D, Hsueh EC, Pak H, Trezona TP, Davidson RS, McPhee M, Guenther JM, Toomey P, Smith FO, Beitsch PD, Lewis JM, Ward A, Young SE, Shah PK, Quick AP, Martin BJ, Zolochevska O, Covington KR, Monzon FA, Goldberg MS, Cook RW, Fleming MD, Hyams DM, Vetto JT. Integrating 31-Gene Expression Profiling With Clinicopathologic Features to Optimize Cutaneous Melanoma Sentinel Lymph Node Metastasis Prediction. JCO Precis Oncol. 2021 Sep 13;5:PO.21.00162. doi: 10.1200/PO.21.00162. eCollection 2021.
- Hsueh EC, DeBloom JR, Lee JH, Sussman JJ, Covington KR, Caruso HG, Quick AP, Cook RW, Slingluff CL Jr, McMasters KM. Long-Term Outcomes in a Multicenter, Prospective Cohort Evaluating the Prognostic 31-Gene Expression Profile for Cutaneous Melanoma. JCO Precis Oncol. 2021 Apr 6;5:PO.20.00119. doi: 10.1200/PO.20.00119. eCollection 2021.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EXPAND_1_Protocol- Amendment 1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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