TY - JOUR

T1 - RNA analysis of tape strips to rule out melanoma in lesions clinically assessed as cutaneous malignant melanoma

T2 - A diagnostic study

AU - Heerfordt, Ida M.

AU - Philipsen, Peter A.

AU - Andersen, Jeppe D.

AU - Langhans, Linnea

AU - Schmidt, Grethe

AU - Morling, Niels

AU - Wulf, Hans Christian

N1 - Funding Information: Funding sources: This work was funded by M.L. Jørgensen og Gunnar Hansens Fond , Denmark. The funder had no additional role in the study. Publisher Copyright: © 2023 American Academy of Dermatology, Inc.

PY - 2023

Y1 - 2023

N2 - Background: Distinguishing cutaneous malignant melanoma (CMM) from nevi can be clinically challenging. Suspicious lesions are therefore excised, resulting in many benign lesions being removed surgically to find 1 CMM. It has been proposed to use tape strip derived ribonucleic acid (RNA) to distinguish CMM from nevi. Objective: To develop this technique further and validate if RNA profiles can rule out CMM in clinically suspicious lesions with 100% sensitivity. Methods: Before surgical excision, 200 lesions clinically assessed as CMM were tape stripped. Expression levels of 11 genes on the tapes were investigated by RNA measurement and used in a rule-out test. Results: Histopathology showed that 73 CMMs and 127 non-CMMs were included. Our test correctly identified all CMMs (100% sensitivity) based on the expression levels of 2 oncogenes, PRAME and KIT, relative to a housekeeping gene. Patient age and sample storage time were also significant. Simultaneously, our test correctly excluded CMM in 32% of non-CMM lesions (32% specificity). Limitations: Our sample contained a very high proportion of CMMs, perhaps due to inclusion during COVID-19 shutdown. Validation in a separate trial must be performed. Conclusion: Our results demonstrate that the technique can reduce removal of benign lesions by one-third without overlooking any CMMs.

AB - Background: Distinguishing cutaneous malignant melanoma (CMM) from nevi can be clinically challenging. Suspicious lesions are therefore excised, resulting in many benign lesions being removed surgically to find 1 CMM. It has been proposed to use tape strip derived ribonucleic acid (RNA) to distinguish CMM from nevi. Objective: To develop this technique further and validate if RNA profiles can rule out CMM in clinically suspicious lesions with 100% sensitivity. Methods: Before surgical excision, 200 lesions clinically assessed as CMM were tape stripped. Expression levels of 11 genes on the tapes were investigated by RNA measurement and used in a rule-out test. Results: Histopathology showed that 73 CMMs and 127 non-CMMs were included. Our test correctly identified all CMMs (100% sensitivity) based on the expression levels of 2 oncogenes, PRAME and KIT, relative to a housekeeping gene. Patient age and sample storage time were also significant. Simultaneously, our test correctly excluded CMM in 32% of non-CMM lesions (32% specificity). Limitations: Our sample contained a very high proportion of CMMs, perhaps due to inclusion during COVID-19 shutdown. Validation in a separate trial must be performed. Conclusion: Our results demonstrate that the technique can reduce removal of benign lesions by one-third without overlooking any CMMs.

KW - diagnostic tool

KW - gene expression

KW - KIT

KW - melanoma

KW - nevi

KW - noninvasive

KW - PRAME

U2 - 10.1016/j.jaad.2023.05.030

DO - 10.1016/j.jaad.2023.05.030

M3 - Journal article

C2 - 37224970

AN - SCOPUS:85161038803

VL - 89

SP - 537

EP - 543

JO - American Academy of Dermatology. Journal

JF - American Academy of Dermatology. Journal

SN - 0190-9622

IS - 3

ER -