Melanoma Cancer Malignant melanoma of skin, unspecified
Conditions
Interventions
PRAME expression will be scored by visual estimation as 0, 1+ (1-25%), 2+, (26-50%), 3+ (51-75%), or 4+ (76-100%), utilizing a corresponding MART1 stained slide to help determine the localization and
Sponsors
University of Kansas Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Pathology sample of a primary pigmented skin lesion 2. PRAME immunohistochemistry performed on that sample prior to final diagnosis 3. MART1 immunohistochemistry performed on that sample prior to final diagnosis
Exclusion criteria
Exclusion criteria: 1. Uncertain final diagnosis (e.g., MELTUMP) 2. Re-excision 3. Spindle cell melanoma 4. Desmoplastic melanoma 5. Metastatic melanoma 6. Nonmelanocytic lesion 7. Missing slides 8. Unreadable PRAME or MART1 slides due to technical error
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diagnosis of melanoma in the final pathology report at baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Diagnostic accuracy of 2+ (> 25%) PRAME positivity at baseline 2. Diagnostic accuracy of 3+ (> 50%) PRAME positivity at baseline 3. Diagnostic accuracy of 4+ (> 75%) PRAME positivity at baseline 4. Diagnostic accuracy of hotspot 4+ PRAME positivity (two adjacent 40X fields) at baseline 5. Diagnostic accuracy of single hotspot 4+ PRAME positivity (single 40X field) at baseline 6. Interrater concordance of visual estimates of PRAME positivity at baseline PRAME is measured by microscopic examination of immunostained slides on a score of 0-4+ (0 = 0% of lesional melanocytes are positive; 1+ = 1-25% of lesional melanocytes are positive; 2+ = 26-50% of lesional melanocytes are positive; 3+ = 51-75% of lesional melanocytes are positive; and 4+ = 76-100% of lesional melanocytes are positive) | — |
Countries
United States of America
Outcome results
None listed