Clinical performance of the Nevisense system in cutaneous melanoma detection: an international, multicentre, prospective and blinded clinical trial on efficacy and safety.
Bottom Line: All eligible skin lesions in the study were examined with the EIS-based Nevisense system, photographed, removed by excisional biopsy and subjected to histopathological evaluation.The positive and negative predictive values of Nevisense were 21·1% and 98·2%, respectively.The observed sensitivity for nonmelanoma skin cancer was 100% (55 of 48 BCCs and seven SCCs) with an exact two-sided 95% confidence bound estimated at 93·5-100·0%.
Affiliation: Department of Dermatology, Hospital Clinic, IDIBAPS, University of Barcelona, Barcelona, Spain.Show MeSH
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Mentions: The dichotomous outcome of the Nevisense system was compared with the HGS. Of the 1943 eligible and evaluable lesions (Table4), 265 (13·2%) were cutaneous melanoma, 55 (2·8%) were nonmelanoma skin cancer (NMSC), including basal cell carcinomas (BCCs) and squamous cell carcinomas (SCCs), of which Nevisense correctly identified 256 melanomas and all 55 NMSCs, yielding an observed sensitivity of 96·6% and 100·0%, respectively. A total of 157 naevi with severe dysplasia were included, of which Nevisense gave a positive reading for malignancy in 132 cases. Seven out of eight actinic keratoses gave a positive reading. One Merkel cell carcinoma was included, which was correctly identified as malignant. Out of the remaining 1457 lesions, 501 were diagnosed as negative, yielding an observed specificity of 34·4%. No significant difference in the presented sensitivity and specificity was encountered, when the possible dependency in outcome between the lesions of the same patient was accounted for through a generalized linear mixed model. The positive predictive value (PPV) of Nevisense was 21·1% and the negative predictive value (NPV) was 98·2%. The Nevisense score was compared with lesion severity and, as can be discerned from Figure1, a clear step function is evident for the score outcome with increasing lesion severity.
Affiliation: Department of Dermatology, Hospital Clinic, IDIBAPS, University of Barcelona, Barcelona, Spain.