Circulating Blood Profile to Predict Recurrence and Response to Systemic Therapy

Vanderbilt University Medical Center

Status: Completed

Conditions: Melanoma

Treatments: Other: Blood draw (before surgery); Other: Blood draw (at diagnosis); Other: Blood draw (every 3 months)

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03267381

VICC MEL 1783

Details and patient eligibility

About

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.

Full 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.

Enrollment: 37 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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%

Trial design

37 participants in 3 patient groups

Arm 1a

Description:

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).

Treatment:

Other: Blood draw (every 3 months)

Other: Blood draw (before surgery)

Arm 1b

Description:

Stage III after sentinel node biopsy (microscopic disease diagnosed on sentinel node biopsy).

Treatment:

Other: Blood draw (every 3 months)

Other: Blood draw (before surgery)

Arm 2

Description:

Stage IV- will need to stratify by current treatment with immunotherapy, targeted therapy, none

Treatment:

Other: Blood draw (at diagnosis)

Other: Blood draw (before surgery)