NCT05126173已完成不适用
A Clinical Validation Study to Demonstrate the Effectiveness of an Artificial Intelligence Algorithm (DERM) to Identify Skin Cancer in Patients Undergoing a Skin Biopsy
Skin Analytics Limited16 个研究点 分布在 2 个国家目标入组 1,111 人开始时间: 2022年3月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,111
- 试验地点
- 16
- 主要终点
- Specificity of DERM to detect Malignant conditions.
研究概览
简要总结
This study aims establish the effectiveness of Image Analysing Algorithm (DERM) to identify melanoma, Squamous Cell Carcinoma (SCC) and Basal Cell Carcinoma (BCC) when used to analyse dermoscopic images of skin lesions within the US and European population.
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
- •Willing and able to give informed consent for participation in the study,
- •Male or Female, aged 18 years or above,
- •Have at least one suitable skin lesion that will be biopsied due to a suspicion of skin cancer,
- •To be suitable for inclusion, a skin lesion must NOT have ANY of the following limitations:
- •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), a diameter greater than the diameter of the dermoscopic lenses, located on an anatomical site unsuitable for photographing, including on surface of genitals and hair-bearing areas, has been previously biopsied, excised, treated or otherwise traumatised, 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
Specificity of DERM to detect Malignant conditions.
时间窗: Through study completion, on average of 1 day
Specificity of DERM to detect Melanoma, SCC and BCC combined
Sensitivity of DERM to detect "Malignant conditions"
时间窗: Through study completion, on average of 1 day
Sensitivity of DERM to detect Melanoma, SCC and BCC combined
次要结局
- Sensitivity of DERM to detect Melanoma(Through study completion, on average of 1 day)
- Specificity of DERM to detect Basal Cell Carcinoma(Through study completion, on average of 1 day)
- Accuracy of mole/not mole algorithm(Through study completion, on average of 1 day)
- Sensitivity of DERM to detect Squamous Cell Carcinoma(Through study completion, on average of 1 day)
- Specificity of DERM to detect Squamous Cell Carcinoma(Through study completion, on average of 1 day)
- Specificity of DERM to detect Melanoma(Through study completion, on average of 1 day)
- Sensitivity of DERM to detect Basal Cell Carcinoma(Through study completion, on average of 1 day)
研究者
研究点 (16)
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