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Study endpoints completed with lower than anticipated enrollment. Last patient enrolled completed final visit February 2021.
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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.
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| Measure | Description | Time Frame |
|---|---|---|
| Adjusted surveillance regimen |
| upon receipt DecisionDX-Melanoma results received and every 6 months thereafter |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Early referral to medical oncologist for high risk patients. | referral | Upon Receipt DecisionDx-Melanoma results |
Inclusion Criteria:
Exclusion Criteria:
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Patients with cutaneous melanoma for whom DecisionDx-Melanoma testing is to be clinically performed.
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| Name | Affiliation | Role |
|---|---|---|
| Robert Cook, PhD | Castle Biosciences Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northside Hospital | Atlanta | Georgia | 30342 | United States | ||
| University of Louisville |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34568719 | Derived | 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. | |
| 34036233 |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| Louisville |
| Kentucky |
| 40202 |
| United States |
| Saint Louis University | St Louis | Missouri | 63103 | United States |
| Derived |
| 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. |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |