NCT02612168已完成不适用
Effectiveness of an Image Analysing Algorithm to Diagnose Melanoma Compared to Gold Standard Histological Determination
Skin Analytics Limited14 个研究点 分布在 1 个国家目标入组 514 人开始时间: 2017年1月11日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 514
- 试验地点
- 14
- 主要终点
- The Area Under the Curve of a Receiver Operating Characteristic (AUROC) curve of MIAA result, using a maximum likelihood estimation (MLE) from all of the available images of biopsied lesions, compared to the biopsy result
研究概览
简要总结
Prospective, single-arm, cross-sectional, study to establish the effectiveness of MIAA to detect melanoma in pigmented lesions, compared to gold standard histological determination.
详细描述
Skin Analytics Limited have developed an algorithm (MIAA) which reviews photographs of pigmented lesions to determine whether melanoma is likely to be present. This study aims to establish how well MIAA determines the presence or absence of melanoma, compared to a biopsy.
Pigmented lesions that a dermatologist has decided to biopsy, and are suitable for photographing, will be photographed up to five times in a single visit. Three different camera will be used, and two different dermoscopic lens attachments will be used on smartphone cameras. Images will be analysed by MIAA and the results compared to the biopsy result. Clinicians, patients and the statistical analysis team will be blinded to the result of MIAA.
At least 65 pigmented lesions positive for melanoma (as determined by biopsy) are required, which is predicted to mean 1250 patients will be recruited.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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 1 lesion suitable for photographing that is scheduled for biopsy to determine the presence of melanoma,
- •In the Investigators 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 participants 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.
研究组 & 干预措施
All patients
Experimental
Each patient will have any pigmented lesions (PLs) which are due to be biopsied, two PLs not due for biopsy and one patch of healthy skin photographed. Each will be photographed using three cameras: A standard DSLR and two smartphones with a dermoscopic lens attachment. Photographic images will be analysed by Melanoma Image Analysis Algorithm (MIAA)
干预措施: Melanoma Image Analysis Algorithm (MIAA) (Device)
结局指标
主要结局
The Area Under the Curve of a Receiver Operating Characteristic (AUROC) curve of MIAA result, using a maximum likelihood estimation (MLE) from all of the available images of biopsied lesions, compared to the biopsy result
时间窗: Study completion, on average 2 weeks
Compare the MIAA result with the biopsy result
次要结局
- The sensitivity of MIAA, using a MLE from all of the available images of biopsied lesions, compared to the biopsy result(Study completion, on average 2 weeks)
- The sensitivity of MIAA, using a MLE from all of the available images of non-biopsied lesions, compared to clinical assessment(Study completion, on average 2 weeks)
- The positive predictive value of MIAA, using a MLE from all of the available images of non-biopsied lesions, compared to clinical assessment(Study completion, on average 2 weeks)
- The negative predictive value of MIAA, using a MLE from all of the available images of biopsied lesions, compared to the biopsy result(Study completion, on average 2 weeks)
- The specificity of MIAA, using a MLE from all of the available images of biopsied lesions, compared to the biopsy result(Study completion, on average 2 weeks)
- The specificity of MIAA, using a MLE from all of the available images of non-biopsied lesions, compared to clinical assessment(Study completion, on average 2 weeks)
- The positive predictive value of MIAA, using a MLE from all of the available images of biopsied lesions, compared to the biopsy result(Study completion, on average 2 weeks)
- The negative predictive value of MIAA, using a MLE from all of the available images of non-biopsied lesions, compared to clinical assessment(Study completion, on average 2 weeks)
- The false positive rate of MIAA, using a MLE from all of the available images of non-biopsied lesions, compared to clinical assesment(Study completion, on average 2 weeks)
- The false negative rate of MIAA, using a MLE from all of the available images of non-biopsied lesions, compared to clinical assessment(Study completion, on average 2 weeks)
- The false positive rate of MIAA, using a MLE from all of the available images of biopsied lesions, compared to the biopsy result(Study completion, on average 2 weeks)
- The false negative rate of MIAA, using a MLE from all of the available images of biopsied lesions, compared to the biopsy result(Study completion, on average 2 weeks)
- The AUROC of MIAA, using images of biopsied lesions from each of the image capture apparatus combinations, compared to the biopsy result(Study completion, on average 2 weeks)
- The AUROC of MIAA, using images of non-biopsied lesions from each of the image capture apparatus combinations, compared to clinical assessment(Study completion, on average 2 weeks)
- The sensitivity of MIAA, using images of biopsied lesions from each of the image capture apparatus, compared to the biopsy result(Study completion, on average 2 weeks)
- The sensitivity of MIAA, using images of non-biopsied lesions from each of the image capture apparatus, compared to clinical assessment(Study completion, on average 2 weeks)
- The specificity of MIAA, using images of biopsied lesions from each of the image capture apparatus, compared to the biopsy result(Study completion, on average 2 weeks)
- The positive predictive value of MIAA, using images of non-biopsied lesions from each of the image capture apparatus, compared to clinical assessment(Study completion, on average 2 weeks)
- The negative predictive value of MIAA, using images of biopsied lesions from each of the image capture apparatus, compared to the biopsy result(Study completion, on average 2 weeks)
- The negative predictive value of MIAA, using images of non-biopsied lesions from each of the image capture apparatus, compared to clinical assessment(Study completion, on average 2 weeks)
- The false positive rate of MIAA, using images of biopsied lesions from each of the image capture apparatus, compared to the biopsy result(Study completion, on average 2 weeks)
- The false positive rate of MIAA, using images of non-biopsied lesions from each of the image capture apparatus, compared to clinical assessment(Study completion, on average 2 weeks)
- The specificity of MIAA, using images of non-biopsied lesions from each of the image capture apparatus, compared to clinical assessment(Study completion, on average 2 weeks)
- The positive predictive value of MIAA, using images of biopsied lesions from each of the image capture apparatus, compared to the biopsy result(Study completion, on average 2 weeks)
- The false negative rate of MIAA, using images of biopsied lesions from each of the image capture apparatus, compared to the biopsy result(Study completion, on average 2 weeks)
- The false negative rate of MIAA, using images of non-biopsied lesions from each of the image capture apparatus, compared to clinical assessment(Study completion, on average 2 weeks)
- The concordance of MIAA result between each of the image capture apparatus(Study completion, on average 2 weeks)
- The number of adverse events, including adverse device events and serious adverse events.(Study completion, on average 2 weeks)
- The proportion of lesions with 4 images that can be analysed by MIAA(Study completion, on average 2 weeks)
- The proportion of lesions with at least 1 readable images that can be analysed by MIAA,(Study completion, on average 2 weeks)
- The AUROC curve of the MIAA result, using MLE from all of the available images of non-biopsied PLs, compared to the clinical assessment(Study completion, on average 2 weeks)
研究者
研究点 (14)
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