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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 455
- 试验地点
- 1
- 主要终点
- Analyses of histopathology reports of all excised suspectable lesions
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •Lack of informed consent for study participation.
- •Fitzpatrick skin type V-VI.
- •Acute psychiatric illness or acute crisis
结局指标
主要结局
Analyses of histopathology reports of all excised suspectable lesions
时间窗: up to 24 months
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).
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
时间窗: 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 computer-guided risk assessment scores by Vectra® WB360 and FotoFinder® Mole Analyzer and smartphone app.
Analyses of Smartphone app Skin Vision® scoring of pigmented skin lesions (low, medium or high risk)
时间窗: up to 12 months
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).
Analyses of 2D FotoFinder® Mole Analyzer scoring of pigmented skin lesions (0.0 - 1.0)
时间窗: up to 24 months
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).
Analyses of 3D Vectra® WB360 imaging scoring of pigmented skin lesions (0- 10)
时间窗: up to 24 months
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).
次要结局
- Change in FACIT G7 Functional Assessment of Cancer Therapy - General - (7 item version).(up to 24 months)
- Change in Melanoma Worry Scale (MWS)(up to 24 months)
- Change in support need and uptake(up to 24 months)
- Change in Distress thermometer (Patient-reported outcome)(up to 24 months)
- Change in Hospital Anxiety and Depression Scale (HADS)(up to 24 months)
- Patients' subjective experience and evaluation of modern technological examination(up to 24 months)