MElanoma Research Lymph node prediction Implementation National_001 (MERLIN_001)


NCT ID: NCT04759781
Sponsor Protocol Number: MERLIN_001

About this study

This study aims to create a registry for primary melanoma gene-signature to predict sentinel node (SN) status and determine its prognostic value for more accurate staging of SN-negative melanoma patients.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Newly diagnosed (biopsy within 120 days of study enrollment) invasive malignant melanoma of the skin (AJCC 8th edition staging guidelines).
    • pT1b-pT3 (Breslow thickness ≥ 0.8 mm to 4.0 mm) cN0M0; or
    • pT1a (Breslow thickness < 0.8 mm) cN0M0 AND one or more of the following:
      • Mitotic rate ≥ 2/mm2.
      • Patient age at time of primary melanoma biopsy < 40 years old.
      • Presence of lymphovascular invasion.
  •  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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