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.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Melanoma
- Sponsor
- SkylineDx
- Enrollment
- 1820
- Locations
- 9
- Primary Endpoint
- Positive Predictive Value (PPV)
- Status
- Active, not recruiting
- Last Updated
- last year
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.
Investigators
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.
Outcomes
Primary Outcomes
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.
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.
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
- 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)