MERLIN\_001 is a prospective registry study of a primary melanoma gene-signature to predict sentinel node (SN) status and to determine its prognostic value for more accurate staging of SN-negative melanoma patients.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Newly diagnosed patients with invasive malignant melanoma of the skin (AJCC 8th edition staging guidelines) elected to undergo sentinel lymph node biopsy per the treating physician's recommendation.
* Male or female, age ≥18 years.
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.
Primary outcome measure(s)
Negative Predictive Value (NPV) — 2 years after inclusion The predictive capability of the Merlin Assay to identify newly diagnosed primary cutaneous melanoma patients who have a low risk of presenting with a positive sentinel lymph node.
Positive Predictive Value (PPV) — 2 years after inclusion The predictive capability of the Merlin Assay to identify newly diagnosed primary cutaneous melanoma patients who have a low risk of presenting with a positive sentinel lymph node.
Sensitivity and Specificity. — 2 years after inclusion The predictive capability of the Merlin Assay to identify newly diagnosed primary cutaneous melanoma patients who have a low risk of presenting with a positive sentinel lymph node.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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