Circulating Blood Profile to Predict Recurrence and Response to Systemic Therapy

NCT03267381 | Completed

• 1 other identifier: VICC MEL 1783
• Study Type: observational
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Melanoma

Outcome Measures

Primary Outcomes (4)

• Efficacy (stage III)

  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.

  Up to 24 months

• Assay Metrics

  Define the assay metrics for sensitivity and specificity in diagnosis in Stage III and IV tumors.

  Up to 24 months

• Molecular signature levels

  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.

  Up to 24 months

• Efficacy (Stage IV)

  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

  Up to 24 months

Study Arms (3)

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).

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

Arm 1b

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

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

Arm 2

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

Other: Blood draw (before surgery); Other: Blood draw (at diagnosis)

Interventions

Blood draw (before surgery) OTHER

Blood will be drawn before surgery

Arm 1a; Arm 1b; Arm 2

Blood draw (every 3 months) OTHER

Blood will be drawn every 3 months

Arm 1a; Arm 1b

Blood draw (at diagnosis) OTHER

Blood will be drawn at time of diagnosis

Arm 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adults with a diagnosis of stage III or IV melanoma.

You may qualify if:

• Age \> 18 years
• Primary melanoma \> 1 mm in Breslow depth
• 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

You may not qualify if:

• Pregnant patients
• Contraindication to contrasted imaging (due to allergy or renal insufficiency)
• Serum PCV \<30%

Sponsors & Collaborators

• Vanderbilt-Ingram Cancer Center: lead
• Wren Laboratories LLC: collaborator

Study Sites (1)

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Rondi Kauffmann, MD

  vanderbilt Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 25, 2017
• First Posted: August 30, 2017
• Study Start: October 3, 2017
• Primary Completion: September 27, 2023
• Study Completion: September 27, 2023
• Last Updated: December 14, 2023

Record last verified: 2023-12

Locations

US (1)