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Gene test may spare melanoma patients unnecessary surgery

NCT ID NCT04759781

Diagnosis Sponsor: SkylineDx Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 1,820 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2021

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Prospectively collected primary cutaneous melanoma patients who are elected per treating physician's recommendation to undergo sentinel lymph node biopsy.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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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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