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NCT04759781Active, not recruiting

MElanoma Research Lymph Node Prediction Implementation National_001

A Prospective Registry Study of a Primary Melanoma Gene-signature to Predict Sentinel Node (SN) Status and Determine Its Prognostic Value for More Accurate Staging of SN-negative Melanoma Patients.

Source: ClinicalTrials.gov · Last updated 23 Apr 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
1820 (estimated)
First submitted
15 Feb 2021
Start date
25 Aug 2021
Primary completion date
28 Jun 2024
Lead sponsor
SkylineDx
Diseases
Melanoma
NCT number
NCT04759781

What you commit to

  • Study type: Observational
  • Planned participants: 1820
  • From 25 Aug 2021 to the primary completion date, 28 Jun 2024
  • 9 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Other illness

  • Distant metastatic disease (M1a,b,c,d) clinically present at primary diagnosis
  • Ocular, vulvar, perianal or mucosal melanomas or melanocytic tumors of uncertain malignant potential (MELTUMP) or atypical Spitz tumors.

Other

  • Full primary melanoma pathology report unavailable.
  • Documented clinically apparent nodal metastases at diagnosis.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (9)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Michigan
Coordinator of this site? Confirm its status
Ann ArborUnited StatesUnknown status
Emory University School of Medicine
Coordinator of this site? Confirm its status
AtlantaUnited StatesUnknown status
Duke University
Coordinator of this site? Confirm its status
DurhamUnited StatesUnknown status
University of Kentucky
Coordinator of this site? Confirm its status
LexingtonUnited StatesUnknown status
University of Louisville
Coordinator of this site? Confirm its status
LouisvilleUnited StatesUnknown status
Memorial Sloan-Kettering Cancer Center
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status
Mayo Clinic
Coordinator of this site? Confirm its status
RochesterUnited StatesUnknown status
Huntsman Cancer Institute
Coordinator of this site? Confirm its status
Salt Lake CityUnited StatesUnknown status
Moffitt Cancer Center
Coordinator of this site? Confirm its status
TampaUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.