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To study if a targeted gene expression profile of RNA, similar to the NETest, can be isolated from the peripheral blood of patients with melanoma, to identify active disease, provide an assessment of treatment responses, or predict risk of relapse, in conjunction with standard clinical assessment and imaging.
* Evaluate the diagnostic efficacy of a circulating melanoma gene signature in pathologically verified Stage III melanoma at diagnosis (biopsy-proven lymph node positive) and compare this to LDH as a biomarker. * Evaluate the diagnostic efficacy of a circulating melanoma gene signature in pathologically verified Stage IV melanoma (including pre-surgery patients as well as those on either targeted or immunotherapy) and compare this to LDH as a biomarker. * Define the assay metrics for sensitivity and specificity in diagnosis in Stage III and IV tumors. * Monitor molecular signature levels in blood to assess efficacy of this tool as compared to imaging or other biomarkers to define disease progression or treatment responses in Stage III and IV treated patients.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Start Date
October 3, 2017
Primary Completion Date
September 27, 2023
Completion Date
September 27, 2023
Last Updated
December 14, 2023
37
ACTUAL participants
Blood draw (before surgery)
OTHER
Blood draw (every 3 months)
OTHER
Blood draw (at diagnosis)
OTHER
Lead Sponsor
Vanderbilt-Ingram Cancer Center
Collaborators
NCT06066138
NCT05039801
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