Melanoma Clinical Trial

Circulating Blood Profile to Predict Recurrence and Response to Systemic Therapy

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.

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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.

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Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Study is for people with:

Melanoma

Estimated Enrollment:

37

Study ID:

NCT03267381

Recruitment Status:

Recruiting

Sponsor:

Vanderbilt-Ingram Cancer Center

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There is 1 Location for this study

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Vanderbilt-Ingram Cancer Center
Nashville Tennessee, 37232, United States More Info
Rondi Kauffmann
Contact
Rondi Kauffmann, MD
Principal Investigator

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Study is for people with:

Melanoma

Estimated Enrollment:

37

Study ID:

NCT03267381

Recruitment Status:

Recruiting

Sponsor:


Vanderbilt-Ingram Cancer Center

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