Clinical trial · Observational
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.
NCT04759781CI-TRIAL-00109176MERLIN_001active not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Negative Predictive Value (NPV)
- timeFrame
- 2 years after inclusion
- description
- 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.
- measure
- Positive Predictive Value (PPV)
- timeFrame
- 2 years after inclusion
- description
- 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.
- measure
- Sensitivity and Specificity.
- timeFrame
- 2 years after inclusion
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.