MElanoma Research Lymph Node Prediction Implementation National_001 (MERLIN_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.

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.

Study Overview

• Status: Recruiting
• Conditions: Melanoma

• Study Type: Observational
• Enrollment (Estimated): 2340

Contacts and Locations

• Study Contact: Name: Dennie Tempel, PhD; Phone Number: +31107200326; Email: D.Tempel@skylinedx.com
• Study Contact Backup: Name: Ashley van der Spek, MSc; Phone Number: +31107200326; Email: a.vanderspek@skylinedx.com

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33612
      • Recruiting
      • Moffitt Cancer Center
      • Contact: Vernon K. Sondak, MD
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Recruiting
      • Emory University School of Medicine
      • Contact: Michael C. Lowe, MD/MA
  • Kentucky
    • Lexington, Kentucky, United States, 40506
      • Recruiting
      • University of Kentucky
      • Contact: Erin E. Burke, MD
    • Louisville, Kentucky, United States, 40292
      • Recruiting
      • University of Louisville
      • Contact: Michael E. Egger, MD/MPH
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • University of Michigan
      • Contact: Christina V. Angeles, MD
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic
      • Contact: Tina J. Hieken, MD
  • New York
    • New York, New York, United States, 10065
      • Recruiting
      • Memorial Sloan Kettering Cancer Center
      • Contact: Edmund K. Bartlett, MD
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Recruiting
      • Duke University
      • Contact: Georgia M. Beasley, MD, MHSc
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Recruiting
      • Huntsman Cancer Institute
      • Contact: John R. Hyngstrom, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
3-5 year Recurrence-Free Survival (RFS)	Time between the date of sentinel lymph node biopsy procedure and the date of first melanoma recurrence (loco-regional or distant metastasis) or date of death (whatever the cause), whichever occurs first.	3-5 years after patient inclusion
3-5 year Distant Metastasis-Free Survival (DMFS)	Time between the date of sentinel lymph node biopsy procedure and the date of first distant metastasis or date of death (whatever the cause), whichever occurs first.	3-5 years after patient inclusion
3-5 year Overall Survival (OS)	Time between the date of sentinel lymph node biopsy procedure and the date of death (whatever the cause).	3-5 years after patient inclusion

Collaborators and Investigators

• Sponsor: SkylineDx
• Investigators: Principal Investigator: 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

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2021
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): August 1, 2028

Study Registration Dates

• First Submitted: February 15, 2021
• First Submitted That Met QC Criteria: February 17, 2021
• First Posted (Actual): February 18, 2021

Study Record Updates

• Last Update Posted (Actual): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 21, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: melanoma; assay; gene expression; prospective study; Merlin
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Melanoma
• Other Study ID Numbers: MERLIN_001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No