RNA analysis of tape strips to rule out melanoma in lesions clinically assessed as cutaneous malignant melanoma: A diagnostic study

J Am Acad Dermatol. 2023 Sep;89(3):537-543. doi: 10.1016/j.jaad.2023.05.030. Epub 2023 May 22.

Abstract

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.

Keywords: KIT; PRAME; diagnostic tool; gene expression; melanoma; nevi; noninvasive.

MeSH terms

  • Antigens, Neoplasm
  • COVID-19 Testing
  • COVID-19*
  • Humans
  • Melanoma* / diagnosis
  • Melanoma* / genetics
  • Melanoma* / pathology
  • Melanoma, Cutaneous Malignant
  • Nevus* / diagnosis
  • Nevus* / genetics
  • RNA
  • Skin Neoplasms* / diagnosis
  • Skin Neoplasms* / genetics
  • Skin Neoplasms* / surgery

Substances

  • RNA
  • PRAME protein, human
  • Antigens, Neoplasm