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Active, not recruiting

NCT Number: NCT04759781

MElanoma Research Lymph Node Prediction Implementation National_001

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.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Melanoma Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cranial Nerve Diseases Cranial Nerve Neoplasms Ear Diseases Genetic Diseases, Inborn Heredodegenerative Disorders, Nervous System Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neoplastic Syndromes, Hereditary Nerve Sheath Neoplasms Nervous System Diseases Neurilemmoma Neurocutaneous Syndromes Neurodegenerative Diseases Neuroectodermal Tumors Neuroendocrine Tumors Neurofibroma Neurofibromatoses Neurofibromatosis 2 Neuroma Neuroma, Acoustic Nevi and Melanomas Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Retrocochlear Diseases Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Vestibulocochlear Nerve Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Moffitt Cancer Center, Tampa, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Negative Predictive Value (NPV)

    Time frame: 2 years after inclusion

    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. Positive Predictive Value (PPV)

    Time frame: 2 years after inclusion

    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.

  3. Sensitivity and Specificity.

    Time frame: 2 years after inclusion

    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.

Secondary outcomes

  1. 3-5 year Recurrence-Free Survival (RFS)

    Time frame: 3-5 years after patient inclusion

    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.

  2. 3-5 year Distant Metastasis-Free Survival (DMFS)

    Time frame: 3-5 years after patient inclusion

    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. 3-5 year Overall Survival (OS)

    Time frame: 3-5 years after patient inclusion

    Time between the date of sentinel lymph node biopsy procedure and the date of death (whatever the cause).

Sponsors and collaborators

Lead sponsor

SkylineDx

Industry

Registry information

Official study title

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.

Acronym: MERLIN_001

Important dates

Study start
2021
Primary completion
2024
Study completion
2029
First posted
Feb 18, 2021
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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