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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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 2 years after inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3-5 years after patient inclusion |
| 3-5 year Distant Metastasis-Free Survival (DMFS) |
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Inclusion Criteria:
Exclusion Criteria:
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Prospectively collected primary cutaneous melanoma patients who are elected per treating physician's recommendation to undergo sentinel lymph node biopsy.
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| Name | Affiliation | Role |
|---|---|---|
| Vernon K. Sondak, MD | Moffitt Cancer Center | Principal Investigator |
| Tina J. Hieken, MD | Mayo Clinic | Principal Investigator |
| Michael E. Egger, MD, MPH | University of Louisville | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moffitt Cancer Center | Tampa | Florida | 33612 | United States | ||
| Emory University School of Medicine |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| D016518 | Neurofibromatosis 2 |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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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. |
| 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). | 3-5 years after patient inclusion |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| University of Kentucky | Lexington | Kentucky | 40506 | United States |
| University of Louisville | Louisville | Kentucky | 40292 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Duke University | Durham | North Carolina | 27705 | United States |
| Huntsman Cancer Institute | Salt Lake City | Utah | 84112 | United States |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D009464 | Neuroma, Acoustic |
| D009442 | Neurilemmoma |
| D017253 | Neurofibromatoses |
| D009455 | Neurofibroma |
| D018317 | Nerve Sheath Neoplasms |
| D009463 | Neuroma |
| D009386 | Neoplastic Syndromes, Hereditary |
| D000160 | Vestibulocochlear Nerve Diseases |
| D012181 | Retrocochlear Diseases |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D010039 | Otorhinolaryngologic Neoplasms |
| D003390 | Cranial Nerve Neoplasms |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D020752 | Neurocutaneous Syndromes |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |