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.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04759781

Acronym

MERLIN_001

Enrollment

1820

Registered

2021-02-18

Start date

2021-08-25

Completion date

2029-06-01

Last updated

2026-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melanoma

Keywords

prospective study, gene expression, melanoma, Merlin, assay

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Negative Predictive Value (NPV)	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.
Positive Predictive Value (PPV)	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.
Sensitivity and Specificity.	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

Measure	Time frame	Description
3-5 year Recurrence-Free Survival (RFS)	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.
3-5 year Distant Metastasis-Free Survival (DMFS)	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.
3-5 year Overall Survival (OS)	3-5 years after patient inclusion	Time between the date of sentinel lymph node biopsy procedure and the date of death (whatever the cause).

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORVernon K. Sondak, MD

Moffitt Cancer Center

PRINCIPAL_INVESTIGATORTina J. Hieken, MD

Mayo Clinic

PRINCIPAL_INVESTIGATORMichael E. Egger, MD, MPH

University of Louisville

Outcome results