Circulating Blood Profile to Predict Recurrence and Response to Systemic Therapy
Purpose
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.
Condition
- Melanoma
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- Pregnant patients 2. Contraindication to contrasted imaging (due to allergy or renal insufficiency) 3. Serum PCV <30%
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Case-Control
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Arm 1a | 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). |
|
| Arm 1b | Stage III after sentinel node biopsy (microscopic disease diagnosed on sentinel node biopsy). |
|
| Arm 2 | Stage IV- will need to stratify by current treatment with immunotherapy, targeted therapy, none |
|
More Details
- Status
- Completed
- Sponsor
- Vanderbilt-Ingram Cancer Center
Study Contact
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.