Melanoma Detection in Switzerland With VECTRA

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Melanoma (Skin)

Intervention / Treatment
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* Device: 3D imaging Total Body Photography Vectra® WB360
* Device: 2D imaging FotoFinder ATBM® Master imaging system
* Device: Smartphone application (SkinVision®)
* Other: Standard-of-care clinical assessment of the skin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent of the patient Sufficient fluency in German language skills to complete all questionnaires of the study without external assistance High-risk criteria for melanoma. For high risk one of the following criteria needs to be fulfilled: At least one previous melanoma (including melanoma in situ) A diagnosis of ≥ 100 nevi A diagnosis of ≥ 5 atypical nevi A diagnosis of dysplastic nevus syndrome or known CDKN2A mutation A strong family history (≥ 1 first- and/or second-degree relatives) Exclusion Criteria: Lack of informed consent for study participation. Fitzpatrick skin type V-VI. Acute psychiatric illness or acute crisis

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: 3D imaging Total Body Photography Vectra® WB360|3D Total Body Photography Vectra® WB360 (Canfield Scientific, Parsippany, New Jersey, USA) and its digital dermoscopic camera (VISIOMED® D200evo dermatoscope) and scoring of pigmented skin lesions. All participants of this study will undergo 3D TBP at baseline and the follow-up visits up to month 24.|
|Device: 2D imaging FotoFinder ATBM® Master imaging system|2D imaging with FotoFinder® Mole Analyzer and scoring of pigmented skin lesions. All participants of this study will undergo 2D imaging FotoFinder ATBM® Master imaging system at baseline and the follow-up visits up to month 24.|
|Device: Smartphone application (SkinVision®)|Smartphone application for all dermatoscopically documented pigmented skin lesions in all study participations and record of risk assessment of the health application (low, medium or high risk) to compare the app's accuracy in risk assessment with the AI tools and the dermatologist. The SkinVision® smartphone app is CE certified.of skin lesions. All participants of this study will undergo Smartphone application (SkinVision®) at baseline and the follow-up visits up to month 12.|
|Other: Standard-of-care clinical assessment of the skin|Clinical skin examination with dermatoscope by an experienced dermatologist and risk assessment of pigmented lesions (melanoma vs. naevus). All participants of this study will undergo Standard-of-care clinical assessment of the skin at baseline and the follow-up visits up to month 24.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analyses of histopathology reports of all excised suspectable lesions | The primary outcome, the sensitivity of human and artificial intelligence in detecting melanoma, will be measured at every study visit in case of a suspected melanoma by analysing histopathology reports of all excised suspectable lesions. The diagnosis of melanoma will be confirmed by histology. The biopsied pigmented skin lesions will be categorized as benign (melanocytic nevi / dysplastic nevi) or malignant (melanoma). | up to 24 months | 
| Analyses of dermatologists' assessment of each pigmented skin lesion as benign (melanocytic nevi / dysplastic nevi) or malignant (melanoma) before and after (without and with knowledge of) computer-guided risk assessment scores | Analyses of dermatologists' assessment of each pigmented skin lesion as benign (melanocytic nevi / dysplastic nevi) or malignant (melanoma) before and after computer-guided risk assessment scores by Vectra® WB360 and FotoFinder® Mole Analyzer and smartphone app. | up to 24 months | 
| Analyses of 2D FotoFinder® Mole Analyzer scoring of pigmented skin lesions (0.0 - 1.0) | The primary outcome, the sensitivity of human and artificial intelligence in detecting melanoma, will be measured at every study visit in case of a suspected melanoma by 2D FotoFinder® Mole Analyzer scoring of pigmented skin lesions (0.0 - 1.0). Scores 0.0 - 1.0; 0 indicating no suspicion for melanoma, 1 indicating a high suspicion for melanoma). | up to 24 months | 
| Analyses of 3D Vectra® WB360 imaging scoring of pigmented skin lesions (0- 10) | The primary outcome, the sensitivity of human and artificial intelligence in detecting melanoma, will be measured at every study visit in case of a suspected melanoma by analysing 3D Vectra® WB360 imaging scoring of pigmented skin lesions (0- 10). Score 0 - 10; 0 indicating no suspicion for melanoma, 10 indicating a high suspicion for melanoma). | up to 24 months | 
| Analyses of Smartphone app Skin Vision® scoring of pigmented skin lesions (low, medium or high risk) | The primary outcome, the sensitivity of human and artificial intelligence in detecting melanoma, will be measured at every study visit in case of a suspected melanoma by analysing Smartphone app Skin Vision® scoring of pigmented skin lesions (low, medium or high risk). | up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Distress thermometer (Patient-reported outcome) | Distress thermometer on a scale from 0-10 to address psychological distress: German version of the NCCN Distress Thermometer is used with Problem List (PL) as the screening tool for self-reported psychosocial distress, and to identify the causes of expressed distress. | up to 24 months | 
| Change in FACIT G7 Functional Assessment of Cancer Therapy - General - (7 item version). | The FACIT Measurement System is a collection of QOL questionnaires targeted to the management of chronic illness. | up to 24 months | 
| Change in Hospital Anxiety and Depression Scale (HADS) | The HADS is a 14-item self-administered questionnaire widely used to detect anxiety and depression in physically ill patients and is validated for the German language. The questionnaire has two subscales (anxiety and depression) with seven items each and a total score for each subscale (values from 0-21). Subscale scores between 0-7 indicate normal anxiety and depression levels, scores between 8-10 indicate borderline levels of anxiety and depression, and scores between 11-21 indicate clinical levels of anxiety or depression | up to 24 months | 
| Change in Melanoma Worry Scale (MWS) | MWS comprises four items, score 1 to 4, with possible scores ranging from 4 to 17, a higher score indicating higher levels of worry | up to 24 months | 
| Change in support need and uptake | Support need and uptake will be collected by questions regarding participants' prospective intention to use psycho-oncological support services (Do you intend to use the in-house psycho-oncological support service in the next months?, answer options: yes, maybe, no), the recommendation by the dermatologist for psychological support as well as patients' real uptake (hospital record). | up to 24 months | 
| Patients' subjective experience and evaluation of modern technological examination | Study specific questions concerning the individuals' perceptions focusing the benefits by potentially improved sensitivity and specificity and possible disadvantages of the additional technology (3D TBP) in melanoma screening will be asked. The psychological impact of 3D TBP usage in melanoma screening and its effect on patients' cancer worry will be evaluated. | up to 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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3D total body photography (TBP), 2D sequential digital dermatoscopic imaging (SDDI), skin malignancy, artificial intelligence (AI)- based tools, 3D TBP Vectra® WB360 system, FotoFinder ATBM® Master, SkinVision®