跳至主要内容
临床试验/NCT02902822
NCT02902822已完成不适用

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)

Centro Studi Gised2 个研究点 分布在 1 个国家目标入组 461 人开始时间: 2016年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
461
试验地点
2
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

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.

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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