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OpenTrials
Completed

NCT Number: NCT03267381

Circulating Blood Profile to Predict Recurrence and Response to Systemic Therapy

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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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232, United States

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%

Treatment and study plan

Blood draw (before surgery)

Other

Blood will be drawn before surgery

Blood draw (every 3 months)

Other

Blood will be drawn every 3 months

Blood draw (at diagnosis)

Other

Blood will be drawn at time of diagnosis

Primary outcomes

  1. Efficacy (stage III)

    Time frame: 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.

  2. Assay Metrics

    Time frame: Up to 24 months

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

  3. Molecular signature levels

    Time frame: 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.

  4. Efficacy (Stage IV)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Vanderbilt-Ingram Cancer Center

Other

Collaborators

  • Wren Laboratories LLC

Registry information

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
Aug 30, 2017
Registry last updated
Dec 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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