Our data suggest that the angiogenic serum factors VEGF, bFGF, and IL-8 are useful predictive markers for overall and progression-free survival in melanoma patients.
BF-200 ALA is a very effective, well-tolerated new formulation for AK treatment with PDT and is superior to a registered MAL medication. Efficacies and adverse events vary greatly with the different light sources used.
SummaryBackgroundEven though progress has been made, the detection of melanoma still poses a challenge. In light of this situation, the Nevisense electrical impedance spectroscopy (EIS) system (SciBase AB, Stockholm, Sweden) was designed and shown to have the potential to be used as an adjunct diagnostic tool for melanoma detection.ObjectivesTo assess the effectiveness and safety of the Nevisense system in the distinction of benign lesions of the skin from melanoma with electrical impedance spectroscopy.MethodsThis multicentre, prospective, and blinded clinical study was conducted at five American and 17 European investigational sites. 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. A postprocedure clinical follow-up was conducted at 7 ± 3 days from the initial measurement. A total of 1951 patients with 2416 lesions were enrolled into the study; 1943 lesions were eligible and evaluable for the primary efficacy end point, including 265 melanomas – 112 in situ and 153 invasive melanomas with a median Breslow thickness of 0·57 mm [48 basal cell carcinomas (BCCs) and seven squamous cell carcinomas (SCCs)].ResultsThe observed sensitivity of Nevisense was 96·6% (256 of 265 melanomas) with an exact one-sided 95% lower confidence bound estimated at 94·2% and an observed specificity of 34·4%, and an exact two-sided 95% confidence bound estimated at 32·0–36·9%. 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%.ConclusionsNevisense is an accurate and safe device to support clinicians in the detection of cutaneous melanoma.What's already known about this topic?Although progress has been made in the detection of melanoma it still poses a challenge.Electrical impedance spectroscopy (EIS) may potentially be used as a diagnostic aid for the detection of melanoma.What does this study add?
In the largest international prospective study of its kind in melanoma detection, the EIS system Nevisense was shown to be both accurate and safe in the lesion cohort studied.
In the absence of a perfect gold standard, the accuracy of a device should be compared with the consensus diagnosis from multiple experts.
has received speaker's honoraria from Almirall Hermal, Biofrontera, Galderma, Meda Pharma and JanssenCilag. C.B. has received speaker's and advisory board member's honoraria from, and has been involved in clinical trials sponsored by Almirall
SummaryBackground The diagnostic criteria for basal cell carcinoma (BCC) using optical coherence tomography (OCT) have been described previously, but the clinical value of these findings remains unknown. Objectives To investigate the diagnostic value of OCT for BCC in a typical clinical setting. The primary efficacy end point was a diagnosis of BCC for each lesion. Secondary end points were the diagnosis of other possible conditions. Methods This was an observational, prospective, multicentre study in which consecutive patients with nonpigmented pink lesions suspicious for BCC underwent clinical assessment, dermoscopy and OCT, with the diagnosis recorded at each stage. Once all diagnoses had been recorded, the histological results were disclosed. In total 164 patients with 256 lesions were recruited. Histology was missing for 21 lesions, leaving 235 lesions in 155 patients for analysis. Results Sixty per cent of lesions (141 of 235) were identified as BCC by histology. A slight increase of sensitivity was noted following OCT, which did not reach statistical significance. The specificity increased significantly from 28Á6% by clinical assessment to 54Á3% using dermoscopy and to 75Á3% with the addition of OCT (P < 0Á001). The positive predictive value for the diagnosis of BCC using OCT was 85Á2% [95% confidence interval (CI) 78Á6-90Á4], and the negative predictive value was 92Á1% (95% CI 83Á6-97Á0). The accuracy of diagnosis for all lesions increased from 65Á8% with clinical evaluation to 76Á2% following additional dermoscopy and to 87Á4% with the addition of OCT. Conclusions OCT significantly improved the diagnostic specificity for BCC compared with clinical assessment and dermoscopy alone.
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