MElanoma Research Lymph Node Prediction Implementation National_001

Study Overview
=================
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.

Official 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.

Conditions
-----------------
Melanoma

Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prospective study, gene expression, melanoma, Merlin, assay