Impact on clinical practice of a non-invasive gene expression melanoma rule-out test: 12-month follow-up of negative test results and utility data from a large US registry study

Ferris, Laura K.; Rigel, Darrell S.; Siegel, Daniel M.; Skelsey, Maral K; Peck, Gary L.; Hren, Catherine; Gorman, Christopher; Frumento, Tana; Jansen, Burkhard; Yao, Zuxu; Rock, Jim; Knezevich, Stevan R.; Cockerell, Clay J.

doi:10.5070/d3255044059

Cited by 12 publications

(13 citation statements)

References 23 publications

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“…It is a serious concern that a sensitivity of about 91% to 95%, as found in the previous RNA test based on two genes [ 10 , 12 , 13 ], may result in missed CMMs. A rule-out test of CMM must have a very high sensitivity, close to 100%, to be generally accepted.…”

Section: Discussionmentioning

confidence: 99%

“…LINC00518 and PRAME are known to be overexpressed in CMM, and the test result is deemed positive (indication CMM) or negative (indicating absence of CMM) based on the detection of RNA from one or both genes. The test has a reported sensitivity between 91% and 95% and a specificity between 69% and 91% [ 10 , 12 , 13 ]. The sensitivity level, in particular, has raised concerns about the strength of the RNA test and has resulted in a need for further improvement and validation of the test methods [ 15 , 16 ].…”

Section: Introductionmentioning

confidence: 99%

“…An American research group supported by DermTech (La Jolla, CA, USA) has proposed a non-invasive RNA test to improve the accuracy of CMM diagnostics using RNA profiles sampled with tape strips from the surface of suspicious lesions [8][9][10][11][12][13]. The RNA test is presented as a rule-out test [14].…”

Section: Introductionmentioning

confidence: 99%

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Detection of cutaneous malignant melanoma using RNA sampled by tape strips: A study protocol

et al. 2022

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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).

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Detection of cutaneous malignant melanoma using RNA sampled by tape strips: A study protocol

et al. 2022

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“…In the study, clinicians chose to monitor 98.2% of 743 PLA-negative cases for 12 months without biopsy procedures. None of the 13 lesions for which biopsy specimens were available were diagnosed as melanoma histopathologically [108]. Indeed, the impact of PLA outcomes on clinical decision-making was described in real-world setting studies.…”

Section: Clinical Applications For Specific Skin Cancers Melanomamentioning

confidence: 99%

“…Indeed, the impact of PLA outcomes on clinical decision-making was described in real-world setting studies. About 99% of PLAnegative cases were followed up without biopsy procedures, while 97% of PLA-positive cases underwent histopathological examination [108,109]. The incorporation of PLA in the decision to perform biopsy resulted in a decrease in the total number of biopsies and an increase in the rate of detection of early melanomas [105].…”

Section: Clinical Applications For Specific Skin Cancers Melanomamentioning

confidence: 99%

Emerging Minimally Invasive Technologies for the Detection of Skin Cancer

Jung

Cho

Lee

et al. 2021

JPM

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With the increasing incidence of skin cancer, many noninvasive technologies to detect its presence have been developed. This review focuses on reflectance confocal microscopy (RCM), optical coherence tomography (OCT), high-frequency ultrasound (HFUS), electrical impedance spectroscopy (EIS), pigmented lesion assay (PLA), and Raman spectroscopy (RS) and discusses the basic principle, clinical applications, advantages, and disadvantages of each technology. RCM provides high cellular resolution and has high sensitivity and specificity for the diagnosis of skin cancer. OCT provides lower resolution than RCM, although its evaluable depth is deeper than that of RCM. RCM and OCT may be useful in reducing the number of unnecessary biopsies, evaluating the tumor margin, and monitoring treatment response. HFUS can be mainly used to delineate tumor depths or margins and monitor the treatment response. EIS provides high sensitivity but low specificity for the diagnosis of skin malignancies. PLA, which is based on the genetic information of lesions, is applicable for the detection of melanoma with high sensitivity and moderate-to-high specificity. RS showed high accuracy for the diagnosis of skin cancer, although more clinical studies are required. Advances in these technologies for the diagnosis of skin cancer can lead to the realization of optimized and individualized treatments.

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Dermatologic Disease-Directed Targeted Therapy (D3T2): The Application of Biomarker-Based Precision Medicine for the Personalized Treatment of Skin Conditions—Precision Dermatology

Cohen

Kurzrock

2022

Dermatol Ther (Heidelb)

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Precision dermatology uses individualized dermatologic disease-directed targeted therapy (D 3 T 2 ) for the management of dermatoses and for the evaluation and therapy of cutaneous malignancies. Personalized/precision strategies are based on biomarkers that are most frequently derived from tissue transcriptomic expression or genomic sequencing or from circulating cytokines. For instance, the pathologic diagnosis of a pigmented lesion and determining the prognosis of a malignant melanocytic neoplasm can be enhanced by genomic/transcriptomic analysis. In addition to biopsy, innovative techniques have been developed for

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Impact on clinical practice of a non-invasive gene expression melanoma rule-out test: 12-month follow-up of negative test results and utility data from a large US registry study

Abstract: Impact on clinical practice of a non-invasive gene expression melanoma rule-out test: 12month follow-up of negative test results and utility data from a large US registry study Permalink

Cited by 12 publications

References 23 publications

Detection of cutaneous malignant melanoma using RNA sampled by tape strips: A study protocol

Detection of cutaneous malignant melanoma using RNA sampled by tape strips: A study protocol

Emerging Minimally Invasive Technologies for the Detection of Skin Cancer

Dermatologic Disease-Directed Targeted Therapy (D3T2): The Application of Biomarker-Based Precision Medicine for the Personalized Treatment of Skin Conditions—Precision Dermatology

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