Clinical Trial 21125

• Overview

  Study Title:

  MElanoma Research Lymph Node Prediction Implementation National_001 (MERLIN_001)

  Objective:

  1. The predictive capability of CP-GEP to identify primary cutaneous melanoma patients who can safely forgo sentinel lymph node biopsy 2. The prognostic value of CP-GEP regarding the outcome of cutaneous melanoma patients after a negative sentinel lymph node biopsy.

• Inclusion Criteria

  • Newly diagnosed (biopsy within 120 days of study enrollment) invasive malignant melanoma of the skin; pT1b-pT3 (Breslow thickness ≥0.8 mm to 4.0 mm) cN0M0 OR pT1a (Breslow thickness > Male or female, age ≥18 years.
  • Elected to undergo sentinel lymph node biopsy per the treating physician’s recommendation.

• Exclusion Criteria

  • Full primary melanoma pathology report unavailable.
  • Documented clinically apparent nodal metastases at diagnosis.
  • Distant metastatic disease (M1a,b,c,d) clinically present at primary diagnosis
  • Any prior or concurrent primary invasive melanoma mapping to the same draining lymph node basin(s).
  • Documented history of another (prior or concurrent) primary invasive melanoma of T1b or greater at any site within the last 5 years.
  • Previous surgery in or radiation therapy to the draining lymph node basin(s) of the current primary melanoma.
  • Ocular, vulvar, perianal or mucosal melanomas or melanocytic tumors of uncertain malignant potential (MELTUMP) or atypical Spitz tumors.

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