NCT03267381

Circulating Blood Profile to Predict Recurrence and Response to Systemic Therapy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 37 (actual)
• Sponsor: Vanderbilt-Ingram Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Melanoma

Interventions

Type	Name	Description
OTHER	Blood draw (before surgery)	Blood will be drawn before surgery
OTHER	Blood draw (every 3 months)	Blood will be drawn every 3 months
OTHER	Blood draw (at diagnosis)	Blood will be drawn at time of diagnosis

Timeline

• Start date: 2017-10-03
• Primary completion: 2023-09-27
• Completion: 2023-09-27
• First posted: 2017-08-30
• Last updated: 2023-12-14

Locations

1 site across 1 country: United States