Clinical Trial: Tele-dermatology of Skin Cancer in a Cohort of Local Health Authority Employees in the Province of Bergamo

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: 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

Brief Summary: 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.

Detailed Summary:
Sponsor: Centro Studi Gised

Current Primary Outcome: Cumulative incidence of at least one non-widespread skin lesion identified and clinically confirmed as suspected / highly suspected [ Time Frame: Two years ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Agreement between the tele-dermatology system and the direct dermatological visit as assessed by Cohen's kappa (within the experimental arm). [ Time Frame: 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). [ Time Frame: Within the two years study period ]
  • Proportion of subjects who have at least one anticipated follow-up visit (within the comparator arm). [ Time Frame: Within the two years study period ]
  • Proportion of subjects with at least one missed scheduled visit at follow-up(within the comparator arm). [ Time Frame: Within the two years study period ]


Original Secondary Outcome: Same as current

Information By: Centro Studi Gised

Dates:
Date Received: September 8, 2016
Date Started: October 2016
Date Completion: January 2019
Last Updated: November 8, 2016
Last Verified: November 2016