Melanoma
Conditions
Brief summary
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
* 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.
Interventions
OTHERBlood draw (before surgery)
Blood will be drawn before surgery
OTHERBlood draw (every 3 months)
Blood will be drawn every 3 months
OTHERBlood draw (at diagnosis)
Blood will be drawn at time of diagnosis
Sponsors
Wren Laboratories LLC
Vanderbilt-Ingram Cancer Center
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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%
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy (stage III) | Up to 24 months | 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. |
| Assay Metrics | Up to 24 months | Define the assay metrics for sensitivity and specificity in diagnosis in Stage III and IV tumors. |
| Molecular signature levels | Up to 24 months | 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. |
| Efficacy (Stage IV) | Up to 24 months | 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 |
Countries
United States
Outcome results
None listed