Circulating Blood Profile to Predict Recurrence and Response to Systemic Therapy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Circulating Blood Profile to Predict Recurrence and Response to Systemic Therapy

Conditions
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Melanoma

Intervention / Treatment
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* Other: Blood draw (before surgery)
* Other: Blood draw (every 3 months)
* Other: Blood draw (at diagnosis)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years Primary melanoma > 1 mm in Breslow depth 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: Pregnant patients Contraindication to contrasted imaging (due to allergy or renal insufficiency) Serum PCV <30%

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Arm 1a<br>Stage III melanoma diagnosis (biopsy-proven lymph node positive (this is either clinically palpable or enlarged nodes detected by imaging, which are then biopsied and have macroscopic disease). | Other: Blood draw (before surgery)<br>* Blood will be drawn before surgery<br>Other: Blood draw (every 3 months)<br>* Blood will be drawn every 3 months<br>|
| Arm 1b<br>Stage III after sentinel node biopsy (microscopic disease diagnosed on sentinel node biopsy). | Other: Blood draw (before surgery)<br>* Blood will be drawn before surgery<br>Other: Blood draw (every 3 months)<br>* Blood will be drawn every 3 months<br>|
| Arm 2<br>Stage IV- will need to stratify by current treatment with immunotherapy, targeted therapy, none | Other: Blood draw (before surgery)<br>* Blood will be drawn before surgery<br>Other: Blood draw (at diagnosis)<br>* Blood will be drawn at time of diagnosis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy (stage III) | 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. | Up to 24 months | 
| Assay Metrics | Define the assay metrics for sensitivity and specificity in diagnosis in Stage III and IV tumors. | Up to 24 months | 
| Molecular signature levels | 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. | Up to 24 months | 
| Efficacy (Stage IV) | 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 | Up to 24 months |