MElanoma Research Lymph Node Prediction Implementation National_001

Running, not enrolling

Conditions studied: Melanoma

In brief

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.

Key facts

Study ID

NCT04759781

Run by

SkylineDx

People needed

1820

Starts

2021-08-25

Expected to finish

2029-06-01

Last updated by the study team

2026-04-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Moffitt Cancer Center — Tampa, Florida, United States
• Emory University School of Medicine — Atlanta, Georgia, United States
• University of Kentucky — Lexington, Kentucky, United States
• University of Louisville — Louisville, Kentucky, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Duke University — Durham, North Carolina, United States
• Huntsman Cancer Institute — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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