Circulating Blood Profile to Predict Recurrence and Response to Systemic Therapy

Melanoma Clinical Trial

Official title:

Circulating Blood Profile to Predict Recurrence and Response to Systemic Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03267381
• Other study ID #: VICC MEL 1783
• Status: Completed
• Start date: October 3, 2017
• Est. completion date: September 27, 2023

Study information

• Verified date: December 2023
• Source: Vanderbilt-Ingram Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: September 27, 2023
• Est. primary completion date: September 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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%

Related Conditions & MeSH terms

• Melanoma
• Recurrence

Intervention

Other:
• Blood draw (before surgery)
Blood will be drawn before surgery
• Blood draw (every 3 months)
Blood will be drawn every 3 months
• Blood draw (at diagnosis)
Blood will be drawn at time of diagnosis

Locations

Country	Name	City	State
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt-Ingram Cancer Center	Wren Laboratories LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Assay Metrics	Define the assay metrics for sensitivity and specificity in diagnosis in Stage III and IV tumors.	Up to 24 months
Primary	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
Primary	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