Tele-dermatology of Skin Cancer: a Randomized Trial Comparing Remote Assessment With Conventional Visits in a Cohort of Local Health Authority Employees in the Province of Bergamo (the Shoot the Mole Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 461
- 试验地点
- 1
- 主要终点
- Cumulative incidence of at least one non-widespread skin lesion identified and clinically confirmed as suspected / highly suspected
研究概览
简要总结
The purpose of this study is to demonstrate the validity and utility of a tele-dermatology system in the midterm periodic screening of non-widespread skin lesions of recent onset or for which a specialized early classification is deemed to change the prognosis - including precancerous skin lesions as well as melanoma and non-melanoma skin cancers - compared to control visits at fixed follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects currently working at the Local Health Authority of the province of Bergamo
排除标准
- •Subjects who are not able to use the tele-dermatology system or who have no access to the website or the specific app.
研究组 & 干预措施
Screening
This arm includes all subjects randomized to regular dermatological follow-up visits on annual basis.
干预措施: Screening (Procedure)
Tele-dermatology
This arm includes all subjects randomized to the use of a tele-dermatology system for the evaluation of newly onset non-widespread skin lesions.
干预措施: Tele-dermatology (Device)
结局指标
主要结局
Cumulative incidence of at least one non-widespread skin lesion identified and clinically confirmed as suspected / highly suspected
时间窗: Two years
次要结局
- Agreement between the tele-dermatology system and the direct dermatological visit as assessed by Cohen's kappa (within the experimental arm).(Within the two years study period)
- Cumulative incidence of at least one non-widespread skin lesion identified as suspected / highly suspected among subjects who did not use the tele-dermatology system (within the experimental arm).(Within the two years study period)
- Proportion of subjects with at least one missed scheduled visit at follow-up(within the comparator arm).(Within the two years study period)
- Proportion of subjects who have at least one anticipated follow-up visit (within the comparator arm).(Within the two years study period)