Utility of a Noninvasive 2-Gene Molecular Assay for Cutaneous Melanoma and Effect on the Decision to Biopsy
Utility of a Noninvasive 2-Gene Molecular Assay for Cutaneous Melanoma and Effect on the Decision to Biopsy
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DOI：
10.1001/jamadermatol.2017.0473
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发表时间：
2017-07-01
期刊：
影响因子：
10.9
通讯作者：
Gerami, Pedram
中科院分区：
文献类型：
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作者：
Ferris, Laura K.;Jansen, Burkhard;Gerami, Pedram
重要性通过非侵入性粘附贴片活检获得的长基因间非蛋白编码RNA 518（LINC 00518）和黑色素瘤优先表达抗原（PRAME）基因的表达是检测皮肤黑色素瘤的敏感和特异性方法。然而，皮肤科医生在活检决策中使用该测试的效用尚未评估。目的确定LINC 00518/PRAME表达的色素性病变测定（PLA）在一系列色素性皮肤病变活检决策中的效用。设计、设置和参与者在这个安全的基于网络的多读者多病例研究中，45名委员会认证的皮肤科医生每人评估了60张临床非典型色素性病变的临床和皮肤镜图像，首先没有PLA基因表达信息，然后有PLA基因表达信息，并询问病变是否应该进行活检。从2014年3月24日到2015年11月13日收集数据。干预参与者被给予每个病变的报告，其中包括LINC 00518/PRAME表达的测定结果和PLA评分以及所提供信息的预测值数据。主要结果和指标有与无PLA数据的活检灵敏度和特异性。（29名男性和16名女性）进行了评价。在决定是否对提示黑色素瘤的色素性病变进行活检时，皮肤科医生将PLA纳入其中后，其平均活检敏感性从95.0%提高到98.6%（P= 0.01），特异性从32.1%提高到56.9%（P
IMPORTANCE Expression of long intergenic non-protein coding RNA 518 (LINC00518) and preferentially expressed antigen in melanoma (PRAME) genes, obtained via noninvasive adhesive patch biopsy, is a sensitive and specific method for detection of cutaneous melanoma. However, the utility of this test in biopsy decisions made by dermatologists has not been evaluated.OBJECTIVE To determine the utility of the pigmented lesion assay (PLA) for LINC00518/PRAME expression in decisions to biopsy a series of pigmented skin lesions.DESIGN, SETTING, AND PARTICIPANTS In this secure web-based, multiple-reader-multiple-case study, 45 board-certified dermatologists each evaluated 60 clinical and dermoscopic images of clinically atypical pigmented lesions, first without and then with PLA gene expression information and were asked whether the lesions should be biopsied. Data were collected from March 24, 2014, through November 13, 2015.INTERVENTIONS Participants were given a report for each lesion, which included the results of an assay for expression of LINC00518/PRAME and a PLA score with data on the predictive values of the information provided.MAIN OUTCOMES AND MEASURES Biopsy sensitivity and specificity with vs without PLA data.RESULTS Forty-five dermatologists (29 male and 16 female) performed the evaluation. After incorporating the PLA into their decision as to whether to biopsy a pigmented lesion suggestive of melanoma, dermatologists improved their mean biopsy sensitivity from 95.0% to 98.6%(P=.01); specificity increased from 32.1% to 56.9% (P