A Precision Study To Demonstrate The Repeatability and Reproducability of DERM Outputs
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 115
- 试验地点
- 3
- 主要终点
- Reproducibility: Average Positive Agreement (APA) of DERM on malignant lesions is >80%
研究概览
简要总结
DERM is a Medical Device that uses artificial intelligence to help doctors check if a skin lesion might be cancerous. It works by analysing close-up pictures of skin lesions taken with a smartphone.
This study aims to demonstrate how consistent (precise) the output of DERM is: i.e. does it provide the same result when it analyses multiple photos of the same lesion (repeatability), and when the same lesion is photographed by different people, or with different cameras (reproducibility).
Adults with at least one skin lesion that doctors are checking for cancer, as part of their standard care, will be able to take part. Suitable lesions will be photographed three times, each by three different people using three sets of image capture hardware (specifically, an iPhone 11 with a DL200/HR dermoscopic lens). Each image will be checked for good image quality as it is captured. Images will then be transferred to DERM, where they'll be analysed.
The DERM output won't be shared with the patients or doctors involved in the study. The patients will continue to have their skin lesion biopsy/excised, in accordance with standard of care. Their diagnosis will be collected and compared to the output from DERM.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Male or Female,
- •aged 18 years or above,
- •Willing and able to give informed consent for participation in the study,
- •Has at least one skin lesion that, following assessment by a primary care provider and a dermatology specialist, will be biopsied due to a high suspicion of skin cancer, and is suitable for assessment by DERM.
- •In the Investigator's opinion, able and willing to comply with all study requirements.
排除标准
- •Patients with more than one skin lesion due for biopsy
- •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.
- •To be suitable for inclusion, a skin lesion must NOT have ANY of the following limitations:
- •Be located on an anatomical site of different skin structure: palms of hands or soles of feet (acral lesion), mucosal surfaces (lips and eyes) or under nail (ungal lesion),
- •Have a diameter greater than the diameter of the dermoscopic lens,
- •Be located on an anatomical site unsuitable for photographing, including on surface of genitals and hair-bearing areas,
- •Have been previously biopsied, excised, treated or is otherwise traumatised
- •Be located in an area of visible scarring or tattooing.
结局指标
主要结局
Reproducibility: Average Positive Agreement (APA) of DERM on malignant lesions is >80%
时间窗: 1 day
Each lesion will be imaged by three users using three sets of the image capture hardware, generating nine data sets (user/hardware combinations) per lesion. Each lesion image data set will consist of 3 repeated measures, resulting in 27 measures per lesion
Repeatability: Average Positive Agreement (APA) of DERM on malignant lesions is >80%
时间窗: 1 day
Each lesion will be imaged by three users using three sets of the image capture hardware, generating nine data sets (user/hardware combinations) per lesion. Each lesion image data set will consist of 3 repeated measures, resulting in 27 measures per lesion.
次要结局
- Reproducibility: Average Negative Agreement (ANA) of DERM on benign lesions is >50%(1 day)
- Repeatability: Average Negative Agreement (ANA) of DERM on benign lesions is >50%(1 day)