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.
Study Type
OBSERVATIONAL
Enrollment
1,820
Moffitt Cancer Center
Tampa, Florida, United States
Emory University School of Medicine
Atlanta, Georgia, United States
University of Kentucky
Lexington, Kentucky, United States
University of Louisville
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.
Time frame: 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.
Time frame: 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.
Time frame: 2 years after inclusion
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.
Time frame: 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.
Time frame: 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).
Time frame: 3-5 years after patient inclusion
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Louisville, Kentucky, United States
University of Michigan
Ann Arbor, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Duke University
Durham, North Carolina, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States