Clinical trial NCT04759781: MElanoma Research Lymph Node Prediction Implementation National_001
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.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Melanoma
Keywords: prospective study
gene expression
melanoma
Merlin
assay
Lead sponsor: SkylineDx
Sponsor class: INDUSTRY
First posted: 2021-02-18
Enrollment: 1820
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Prospectively collected primary cutaneous melanoma patients who are elected per treating physician's recommendation to undergo sentinel lymph node biopsy.

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.


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.

Primary outcomes:
measure: Negative Predictive Value (NPV)
timeFrame: 2 years after inclusion
measure: Positive Predictive Value (PPV)
timeFrame: 2 years after inclusion
measure: Sensitivity and Specificity.
timeFrame: 2 years after inclusion
Secondary outcomes:
measure: 3-5 year Recurrence-Free Survival (RFS)
timeFrame: 3-5 years after patient inclusion
measure: 3-5 year Distant Metastasis-Free Survival (DMFS)
timeFrame: 3-5 years after patient inclusion
measure: 3-5 year Overall Survival (OS)
timeFrame: 3-5 years after patient inclusion
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Atlanta
country: United States
facility: Emory University School of Medicine
state: Georgia
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute
state: Utah
Study officials:
affiliation: Moffitt Cancer Center
name: Vernon K. Sondak, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: Tina J. Hieken, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Louisville
name: Michael E. Egger, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: