Effectiveness of an Image Analysing Algorithm (DERM) to Diagnose Non-melanoma Skin Cancer (NMSC) and Benign Skin Lesions Compared to Gold Standard Clinical and Histological Diagnosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 572
- 试验地点
- 3
- 主要终点
- AUROC of DERM performance when analysing images of biopsied lesions
研究概览
简要总结
This study aims to establish the effectiveness of an Artificial Intelligence (AI) algorithm (DERM) to determine the presence of Basal Cell Carcinoma (BCC) and Squamous Cell Carcinoma (SCC) and frequently observed benign conditions, when used to analyse images of skin lesions taken by commonly available smart phone cameras.
详细描述
DERM, an Artificial Intelligence (AI)-based diagnosis support tool, has been shown to be able to accurately identify Non-melanoma skin cancers (NMSC) and other conditions from historical images of suspicious skin lesions (moles). This study aims to establish how well DERM determines the presence of these conditions in images of skin lesions collected in a clinical setting.
Suspicious skin lesions that are due to be assessed by a dermatologist and a patch of healthy skin will be photographed using three commonly available smart phone cameras with a specific lens attachment. The images will be analysed by DERM, and the results compared to the clinician's diagnosis (all lesions) and histologically-conformed diagnosis (any lesion that is biopsied).
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
- •Participant is willing and able to give informed consent for participation in the study,
- •Male or Female, aged 18 years or above,
- •Have at least suspicious skin lesion which is suitable for photographing (<15mm, not located on an anatomical site inappropriate to photograph (genitalia, hair-bearing areas, under nails), not previously biopsied, not located in an area of visible scarring or tattooing),
- •In the Investigator's opinion, able and willing to comply with all study requirements.
排除标准
- •Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study
结局指标
主要结局
AUROC of DERM performance when analysing images of biopsied lesions
时间窗: Study completion
Area Under the Receiver Operating Characteristic Curve (AUROC) of the DERM result of biopsied lesions, using histopathological-confirmed diagnosis as gold standard
次要结局
- The false positive rate of DERM when used to assess non-biopsied lesions(Study completion: on average 2 days)
- The proportion of skin lesions with at least 1 readable image that can be analysed by DERM(Study completion: on average 2 days)
- The specificity of DERM when used to assess biopsied lesions(Study completion: on average 2 days)
- The false positive rate of DERM when used to assess biopsied lesions(Study completion: on average 2 days)
- The positive predictive value of DERM when used to assess biopsied lesions(Study completion: on average 2 days)
- The sensitivity of DERM when used to assess biopsied lesions(Study completion: on average 2 days)
- The sensitivity of DERM when used to assess non-biopsied lesions(Study completion: on average 2 days)
- The specificity of DERM when used to assess non-biopsied lesions(Study completion: on average 2 days)
- Concordance of clinician assessment with histologically confirmed diagnosis(Study completion: on average 2 days)
- The false negative rate of DERM when used to assess biopsied lesions(Study completion: on average 2 days)
- The negative predictive value of DERM when used to assess biopsied lesions(Study completion: on average 2 days)
- The false negative rate of DERM when used to assess non-biopsied lesions(Study completion: on average 2 days)
- The positive predictive value of DERM when used to assess non-biopsied lesions(Study completion: on average 2 days)
- AUROC of DERM performance when analysing images of non-biopsied lesions(Study completion: on average 2 days)
- The negative predictive value of DERM when used to assess non-biopsied lesions(Study completion: on average 2 days)
- The concordance of DERM result generated using images from each camera(Study completion: on average 2 days)
- The proportion of skin lesions with 3 images that can be analysed by DERM;(Study completion: on average 2 days)