MElanoma Research Lymph Node Prediction Implementation National_001

NCT04759781 | Active Not Recruiting

• 1 other identifier: MERLIN_001
• Study Type: observational
• Target: 1,820
• Locations: 1 country
• Sites: 9

Brief Summary

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.

Conditions

Melanoma

Keywords

prospective study; gene expression; melanoma; Merlin; assay

Outcome Measures

Primary Outcomes (3)

• Negative Predictive Value (NPV)

  The predictive capability of the Merlin Assay to identify newly diagnosed primary cutaneous melanoma patients who have a low risk of presenting with a positive sentinel lymph node.

  2 years after inclusion

• Positive Predictive Value (PPV)

  The predictive capability of the Merlin Assay to identify newly diagnosed primary cutaneous melanoma patients who have a low risk of presenting with a positive sentinel lymph node.

  2 years after inclusion

• Sensitivity and Specificity.

  The predictive capability of the Merlin Assay to identify newly diagnosed primary cutaneous melanoma patients who have a low risk of presenting with a positive sentinel lymph node.

  2 years after inclusion

Secondary Outcomes (3)

• 3-5 year Recurrence-Free Survival (RFS)

  3-5 years after patient inclusion

• 3-5 year Distant Metastasis-Free Survival (DMFS)

  3-5 years after patient inclusion

• 3-5 year Overall Survival (OS)

  3-5 years after patient inclusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

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.

Sponsors & Collaborators

• SkylineDx: lead

Study Sites (9)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Emory University School of Medicine

Atlanta, Georgia, 30322, United States

Location

University of Kentucky

Lexington, Kentucky, 40506, United States

Location

University of Louisville

Louisville, Kentucky, 40292, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Duke University

Durham, North Carolina, 27705, United States

Location

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Melanoma; Neurofibromatosis 2

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Neuroma, Acoustic; Neurilemmoma; Neurofibromatoses; Neurofibroma; Nerve Sheath Neoplasms; Neuroma; Neoplastic Syndromes, Hereditary; Vestibulocochlear Nerve Diseases; Retrocochlear Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Otorhinolaryngologic Neoplasms; Cranial Nerve Neoplasms; Cranial Nerve Diseases; Nervous System Diseases; Neurocutaneous Syndromes; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Vernon K. Sondak, MD

  Moffitt Cancer Center

  PRINCIPAL INVESTIGATOR

• Tina J. Hieken, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

• Michael E. Egger, MD, MPH

  University of Louisville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2021
• First Posted: February 18, 2021
• Study Start: August 25, 2021
• Primary Completion: June 28, 2024
• Study Completion (Estimated): June 1, 2029
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)