TY - JOUR

T1 - Detection of cutaneous malignant melanoma using RNA sampled by tape strips

T2 - A study protocol

AU - Heerfordt, Ida M.

AU - Andersen, Jeppe D.

AU - Philipsen, Peter A.

AU - Langhans, Linnea

AU - Tvedebrink, Torben

AU - Schmidt, Grethe

AU - Poulsen, Thomas

AU - Lerche, Catharina M.

AU - Morling, Niels

AU - Wulf, Hans Christian

N1 - Funding Information: This work is funded by M. L. Jørgensen og Gunnar Hansens Fond, Denmark. https://mljghfond.dk/. HCW received the grant without a grant number. The funders had and will not have a role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. We thank laboratory technicians Helle Byrgesen and Nadia Jochumsen and biomedical laboratory scientist Anja Jørgensen, Department of Forensic Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, for their assistance in the laboratory. We acknowledge photographer Nis Kentorp, Department of Dermatology, Copenhagen University Hospital, for helping with the pictures.

PY - 2022

Y1 - 2022

N2 - Background Cutaneous malignant melanoma (CMM) is curable if detected in its early stages. However, the clinical recognition of CMM is challenging. An American research group has shown promising results in detecting CMM based on RNA profiles sampled from suspicious lesions with tape strips. We aim to further develop this technique and validate if RNA profiles sampled with tape strips can detect CMM. Methods This prospective cohort study will include approximately 200 lesions clinically suspected of CMM requiring surgical removal. Tape stripping of the lesions will be performed just before surgical excision. Subsequently, RNA on the tape strips is analyzed using quantitative real-time polymerase chain reaction with TaqMan technology. The results are combined into a binary outcome where positive indicates CMM and negative indicates no CMM. The histopathological diagnosis of the lesions will be used as the gold standard. The main outcome is the results of the RNA test and the histopathological diagnosis, which, combined, provide the sensitivity and specificity of the test. Discussion The accuracy of the clinical examination in CMM diagnostics is limited. This clinical trial will explore the ability to use RNA analysis to improve the management of suspicious lesions by enhancing early diagnostic accuracy. Hopefully, it can reduce the number of benign lesions being surgically removed to rule out CMM and decrease patient morbidity. Trial registration The project was approved by The Committee on Health Research Ethics of the Capital Region of Denmark (H-15010559) and registered at the Danish Data Protection Agency (BFH-2015-065).

AB - Background Cutaneous malignant melanoma (CMM) is curable if detected in its early stages. However, the clinical recognition of CMM is challenging. An American research group has shown promising results in detecting CMM based on RNA profiles sampled from suspicious lesions with tape strips. We aim to further develop this technique and validate if RNA profiles sampled with tape strips can detect CMM. Methods This prospective cohort study will include approximately 200 lesions clinically suspected of CMM requiring surgical removal. Tape stripping of the lesions will be performed just before surgical excision. Subsequently, RNA on the tape strips is analyzed using quantitative real-time polymerase chain reaction with TaqMan technology. The results are combined into a binary outcome where positive indicates CMM and negative indicates no CMM. The histopathological diagnosis of the lesions will be used as the gold standard. The main outcome is the results of the RNA test and the histopathological diagnosis, which, combined, provide the sensitivity and specificity of the test. Discussion The accuracy of the clinical examination in CMM diagnostics is limited. This clinical trial will explore the ability to use RNA analysis to improve the management of suspicious lesions by enhancing early diagnostic accuracy. Hopefully, it can reduce the number of benign lesions being surgically removed to rule out CMM and decrease patient morbidity. Trial registration The project was approved by The Committee on Health Research Ethics of the Capital Region of Denmark (H-15010559) and registered at the Danish Data Protection Agency (BFH-2015-065).

U2 - 10.1371/journal.pone.0274413

DO - 10.1371/journal.pone.0274413

M3 - Journal article

C2 - 36129945

AN - SCOPUS:85138459061

VL - 17

JO - PLoS ONE

JF - PLoS ONE

SN - 1932-6203

IS - 9

M1 - e0274413

ER -