MElanoma Research Lymph Node Prediction Implementation National_001 (MERLIN_001)

SkylineDx

Status: Active, not recruiting

Conditions: Melanoma

Study type: Observational

Funder types: Industry

Identifiers

NCT04759781

MERLIN_001

Details and patient eligibility

About

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.

Enrollment: 1,820 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.