Dermoscopy Evaluation of Pigmented Skin Lesions by a Neuronal Network Clinical Decision Support: an Open Prospective Non Interventional Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Sensitivity for MCT results as compared to biopsy
研究概览
简要总结
Malignant melanoma (MM) is a deadly cancer, claiming globally about 160000 new cases per year and 48000 deaths at a 1:28 lifetime incidence (2016).
The golden standard, dermoscopy, enables Dermatologists to diagnose with a sensitivity of 40%, and a 8-12% specificity, approximately. Additional diagnostic abilities are restricted to devices which are either unproved or experimental.
A new technology of Neuronal Network Clinical Decision Support (NNCD) was developed. It uses a dermoscopic imaging device and a camera able to capture an image. The photo is transferred to a Cloud Server and further analyzed by a trained classifier. Classifier training is aimed at a high accuracy diagnosis of Dysplastic Nevi (DN), Spitz Nevi and Malignant Melanoma detection with assistance from a Deep Neuronal Learning network (DLN). Diagnosis output is an excise or do not excise recommendation for pigmented skin lesions.
A total of 80 subjects already referred to biopsy pigmented skin lesions will be examined by dermoscopy imaging in a non interventional study. Artificial Intelligence output results, as measured by 2 different dermoscopes, to be compared to ground truth biopsies, by either classifier decisions or a novel Modified Classifier Technology output decisions.
Primary endpoints are sensitivity and specificity detection of the NNCD techniques. Secondary endpoints are the positive and negative prediction ratios of NNCD techniques.
详细描述
Background
Malignant melanoma (MM) is a deadly cancer, claiming globally about 160000 new cases per year and 48000 deaths [1]. The incidence rate for MM ascended between 1950 and 2007 more than 17-fold in men (1.9 to 33.5 per 100,000) and more than 9-fold in women (2.6 to 25.3 per 100,000) [2]. It is estimated that 76000 new cases and 9000 deaths are diagnosed/ year (US, only, 2017) [3]. European Countries yield 22000/yr. stage 4 melanomas.
MM starts de novo in about 70% of subjects, with a small 2 millimeters or more superficial skin lesion which, if left undiagnosed, might develop into a more advanced stage cancer, followed by silent lymph node spreading and invasion of vital organs such as liver and brain. MM is staged by either direct invasion into the skin, the Breslow scale in mm, or by its skin level involvement, a Clark 1-5 structural skin level of involvement. Both methods of assessment are predictors of long term survival, which is almost unchanged at a Breslow depth beneath 1 mm and much decreased beyond Clark III stage. Therefore early detection of melanoma, generally tagged as small melanoma, is critical.
Present Methodologies of MM detection
The following different methods and diagnostic means for detection of the cutaneous melanoma are currently employed as a means of diagnosis:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient aged 18-90 years
- •A pigmented lesion by dermoscopy.
- •Clinical management by the examining dermatologist results in biopsy
- •The diameter of the pigmented area is between 1 and 40 millimeters
- •The patient has consented to participate in the study and has signed the Informed Consent Form
排除标准
- •Non intact skin (ulcers, bleeding)
- •The lesion is located within 1 cm of the eye
- •The lesion is located on mucosal surfaces
- •The lesion is on or under nails
结局指标
主要结局
Sensitivity for MCT results as compared to biopsy
时间窗: 15 months
A Sensitivity of at least 85% for Classifier results as compared to biopsy
Sensitivity for Classifier results as compared to biopsy
时间窗: 15 months
A Sensitivity of at least 75% for Classifier results as compared to biopsy
次要结局
- The negative predictive value of MCT(15 months)
- The positive predictive value of MCT(15 months)