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A Robust Discovery Platform for the Identification of Novel Mediators of Melanoma Metastasis

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Gene Expression Profile-Based Test to Predict Melanoma Sentinel Node Status: The MERLIN_001 Study.

Tina J Hieken¹, Michael E Egger², Christina V Angeles³

¹Departments of Surgery and Laboratory Medicine & Pathology, Mayo Clinic, Rochester, Minnesota.

|October 22, 2025

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This summary is machine-generated.

A new combined clinicopathological factors and gene expression profile (CP-GEP) test accurately identifies patients with melanoma at low risk of sentinel lymph node metastasis (SLNM). This test aids in decision-making for sentinel lymph node biopsy (SLNB), potentially sparing patients unnecessary procedures.

Area of Science:

Oncology
Dermatology
Genomics
Surgical Pathology

Background:

Contemporary guidelines recommend sentinel lymph node biopsy (SLNB) for melanoma patients with >10% risk of SLN metastasis.
Accurate identification of low-risk patients can refine SLNB selection, avoiding unnecessary procedures.
A gene expression profile (GEP)-based test offers potential for improved risk stratification.

Purpose of the Study:

To evaluate the predictive capability of a combined clinicopathological factors and GEP (CP-GEP) test.
To identify primary cutaneous melanoma patients who can safely forgo SLNB.
To assess the prognostic value of CP-GEP for outcomes after negative SLNB (not reported herein).

Main Methods:

A multicenter, prospective, blinded prognostic study involving 1761 patients with T1-T3 cutaneous melanoma.

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CP-GEP testing was performed on primary melanoma tissue to assess SLN metastasis risk.

Patients were considered candidates for SLNB based on standard clinical criteria.

Main Results:

The CP-GEP test identified 37.0% of patients as low risk, with a negative predictive value (NPV) of 92.9% for SLN metastasis.
High-risk cases had a significantly higher SLN-positive rate (23.8%) compared to low-risk cases (7.1%).
The proportion of low-risk CP-GEP results decreased with increasing tumor stage (T1: 68.2%, T2: 32.9%, T3: 2.8%).

Conclusions:

The CP-GEP test reliably identifies melanoma patients with a low risk (<10%) of sentinel lymph node metastasis.
SLN metastasis rates were approximately threefold higher in high-risk versus low-risk CP-GEP cases.
CP-GEP may enhance shared decision-making between patients and surgeons regarding SLNB.