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Melanoma Detection in Switzerland With VECTRA — MELVEC  

Melanoma (Skin) Clinical Trial

Official title:
Clinical Performance of the New Artificial-intelligence Powered 3D Total Body Photography System VECTRA® in Early Melanoma Detection and Its Impact on Patients' Burden of Disease: A Prospective Cohort Study in a Real-world Setting

Clinical Trial Summary

This study is to compare 2D- and 3D-imaging and routine clinical care in early melanoma detection in a prospective large-scale real-world data set.

Clinical Trial Description

This study is to compare the accuracy of combining human and artificial intelligence with its independent application in early melanoma detection. The Artificial Intelligence (AI)-powered 3D Total Body Photography (TBP) Vectra® WB360 system's utility and clinical performance in detecting melanoma in the real-world setting will be compared to the gold standard with clinical assessments by experienced dermatologists, to currently widespread used 2D imaging tools (FotoFinder ATBM® Master) and to the Smartphone-based algorithm application (e.g. SkinVision®). Here included are specific questions regarding the patients' subjective experience, acceptance and evaluation of modern technological examination. Additionally, the overall psychological burden and worry of melanoma risk or disease, anxiety, depression will be compared in different groups of patients and psychological support need and real uptake of support and its predictors will be investigated in all participants. To validate the MELVEC (Melanoma Detection in Switzerland with Vectra®) test procedure, an analysis of the measurement repeatability of computer-guided risk assessment scores for early melanoma detection will be performed. A potential benefit of this validation analysis is the optimization of study procedure for future follow-up visits and further enrolled patients in the MELVEC study. Additionally, results will shed light on the reliability of the convolutional neural networks (CNNs) investigated and help formulate recommendations for their current use. Furthermore, results will provide important data for the manufacturers regarding the systems' reliability in clinical application to help future improvement of the respective algorithms. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04605822
Study type Observational
Source University Hospital, Basel, Switzerland
Contact
Status Completed
Phase
Start date January 25, 2021
Completion date January 31, 2024
View Details
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