Circulating Blood Profile to Predict Recurrence and Response to Systemic Therapy

Completed

• Conditions: Melanoma
• Interventions: Other: Blood draw (before surgery); Other: Blood draw (every 3 months); Other: Blood draw (at diagnosis)

• Registration Number: NCT03267381
• Lead Sponsor: Vanderbilt-Ingram Cancer Center

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.

Study Timeline

• Study First Submitted: 2017-08-25
• Study First Submitted QC: 2017-08-25
• Study First Posted: 2017-08-30
• Study Start: 2017-10-03
• Primary Completion: 2023-09-27
• Study Completion: 2023-09-27
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-13
• Last Update Posted: 2023-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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%

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Arm 1a	Blood draw (before surgery)	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 1a	Blood draw (every 3 months)	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 2	Blood draw (before surgery)	Stage IV- will need to stratify by current treatment with immunotherapy, targeted therapy, none
Arm 1b	Blood draw (before surgery)	Stage III after sentinel node biopsy (microscopic disease diagnosed on sentinel node biopsy).
Arm 1b	Blood draw (every 3 months)	Stage III after sentinel node biopsy (microscopic disease diagnosed on sentinel node biopsy).
Arm 2	Blood draw (at diagnosis)	Stage IV- will need to stratify by current treatment with immunotherapy, targeted therapy, none

Primary Outcome Measures

Name	Time	Method
Assay Metrics	Up to 24 months	Define the assay metrics for sensitivity and specificity in diagnosis in Stage III and IV tumors.
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.
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

Trial Locations

Locations (1)

Vanderbilt-Ingram Cancer Center; 🇺🇸 Nashville, Tennessee, United States