Circulating Blood Profile to Predict Recurrence and Response to Systemic Therapy
Circulating Blood Profile to Predict Recurrence and Response to Systemic Therapy
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.
Inclusion Criteria:

 1. Age > 18 years

 2. Primary melanoma > 1 mm in Breslow depth

 3. Stage III or IV disease as determined either by sentinel node biopsy, biopsy of
 clinically enlarged lymph nodes, and/or imaging. If stage IV, must have tissue biopsy
 confirming presence of stage IV melanoma

 Exclusion Criteria:

 1. Pregnant patients

 2. Contraindication to contrasted imaging (due to allergy or renal insufficiency)

 3. Serum PCV <30%