Merry Stephen P, Croghan Ivana T, Dukes Kimberly A, McCormick Brian C, Considine Gerard T, Duvall Michelle J, Thompson Curtis T, Leffell David J
Department of Family Medicine, Mayo Clinic, Rochester, MN, USA.
Department of Internal Medicine, Division of General Internal Medicine, Mayo Clinic, Rochester, MN, USA.
J Prim Care Community Health. 2025 Jan-Dec;16:21501319251344423. doi: 10.1177/21501319251344423. Epub 2025 Jun 5.
To evaluate the performance of noninvasive, elastic scattering spectroscopy, algorithm-powered device (DermaSensor) to detect melanoma and basal and squamous cell cancers in the primary care setting.
PATIENTS & METHODS: DERM-SUCCESS, a blinded, prospective, multicenter pivotal study, enrolled adult patients between August 17, 2020, and December 9, 2021, with lesions that their primary care physicians (PCPs) suspected of skin cancer at clinics in the US (n = 18) and Australia (n = 4). These lesions were assessed by PCPs and scanned with the DermaSensor device. Biopsy specimens were collected, and histopathologic analysis was performed by dermatopathologists. The diagnostic performance of the device, dermatopathologist discordance, and subgroup analyses of clinical interest were calculated.
Of the 1579 skin lesions enrolled, dermatopathologic analysis identified 224 (14.2%) cancers. Device sensitivity was 95.5% (95% CI, 91.7%-97.6%) overall and 96.3% (92.9%-98.4%) for patients in the FDA-approved age group 40 years and older (90.2% for melanoma, 97.8% for basal cell carcinoma, and 97.7% for squamous cell carcinoma). Device specificity was 20.7%. The negative predictive value was 96.6%, and the positive predictive value was 16.6% (NNB 6). The device misclassified as "" rather than "" 4 keratinocyte carcinomas and 4 melanomas in patients aged 40 years or older (n = 8, 0.5% of lesions, 3.7% of cancers biopsied).
The DermaSensor device is an easy-to-use, point-of-care, hand-held skin cancer adjunctive diagnostic device with high sensitivity and NPV to help inform PCP decision-making about skin lesions suspicious for cancer that need further evaluation and those that may be monitored.
评估非侵入性、弹性散射光谱算法驱动设备（皮肤传感器）在基层医疗环境中检测黑色素瘤、基底细胞癌和鳞状细胞癌的性能。
DERM-SUCCESS是一项双盲、前瞻性、多中心关键研究，于2020年8月17日至2021年12月9日招募成年患者，这些患者在美国（n = 18）和澳大利亚（n = 4）的诊所中，其基层医疗医生（PCP）怀疑患有皮肤癌。这些病变由PCP进行评估，并用皮肤传感器设备进行扫描。收集活检标本，由皮肤病理学家进行组织病理学分析。计算该设备的诊断性能、皮肤病理学家的不一致性以及临床感兴趣的亚组分析。
在纳入的1579个皮肤病变中，组织病理学分析确定了224个（14.2%）癌症。该设备的总体敏感性为95.5%（95%CI，91.7%-97.6%），对于美国食品药品监督管理局（FDA）批准的40岁及以上年龄组患者为96.3%（92.9%-98.4%）（黑色素瘤为90.2%，基底细胞癌为97.8%，鳞状细胞癌为97.7%）。该设备的特异性为20.7%。阴性预测值为96.6%，阳性预测值为16.6%（净误诊数6）。该设备将40岁及以上患者中的4例角质形成细胞癌和4例黑色素瘤误分类为“非癌”而非“癌”（n = 8，占病变的0.5%，占活检癌症的3.7%）。
皮肤传感器设备是一种易于使用的即时护理手持式皮肤癌辅助诊断设备，具有高敏感性和阴性预测值，有助于基层医疗医生对可疑皮肤病变做出决策，确定哪些病变需要进一步评估，哪些病变可以进行监测。
