Gene test may spare melanoma patients unnecessary surgery

NCT ID NCT04759781

Ongoing Diagnosis Sponsor: SkylineDx Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing a gene signature (the Merlin Assay) to see if it can accurately predict whether melanoma has spread to nearby lymph nodes. Researchers are enrolling 1,820 newly diagnosed melanoma patients who are scheduled for a sentinel lymph node biopsy. The goal is to determine if the test can identify low-risk patients who might safely skip the biopsy, leading to more precise staging and fewer invasive procedures.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: Merlin Assay (gene signature test)
What this could lead to: If successful, this test could help many melanoma patients avoid unnecessary lymph node biopsies by accurately identifying those at low risk of spread.
What could go wrong: This is an observational registry study, not a treatment trial. The test may not prove accurate enough in practice, and results may not change standard care immediately.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

cutaneous melanoma melanoma Neurofibromatosis 2

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

MELANOMA

Contacts and locations

Locations

Duke University

Durham, North Carolina, 27705, United States
Emory University School of Medicine

Atlanta, Georgia, 30322, United States
Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States
Mayo Clinic

Rochester, Minnesota, 55905, United States
Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States
Moffitt Cancer Center

Tampa, Florida, 33612, United States
University of Kentucky

Lexington, Kentucky, 40506, United States
University of Louisville

Louisville, Kentucky, 40292, United States
University of Michigan

Ann Arbor, Michigan, 48109, United States

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