Circulating Blood Profile to Predict Recurrence and Response to Systemic Therapy

Vanderbilt-Ingram Cancer Center37 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Melanoma

Interventions

Blood draw (before surgery)OTHER

Blood will be drawn before surgery

Blood draw (every 3 months)OTHER

Blood will be drawn every 3 months

Blood draw (at diagnosis)OTHER

Blood will be drawn at time of diagnosis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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%

Locations (1)

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

Outcomes

Primary Outcomes

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.

Time frame: Up to 24 months

Assay Metrics

Define the assay metrics for sensitivity and specificity in diagnosis in Stage III and IV tumors.

Time frame: 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.

Time frame: 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

Time frame: Up to 24 months

Data from ClinicalTrials.gov

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