Tele-dermatology of Skin Cancer in a Cohort of Local Health Authority Employees in the Province of Bergamo
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|ClinicalTrials.gov Identifier: NCT02902822|
Recruitment Status : Completed
First Posted : September 16, 2016
Last Update Posted : May 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Erysipelas Impetigo Herpes Zoster Molluscum Contagiosum Warts Tinea Melanoma Actinic Keratosis Basal Cell Carcinoma Squamous Cell Carcinoma||Procedure: Screening Device: Tele-dermatology||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||461 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Study)|
|Actual Study Start Date :||October 2016|
|Actual Primary Completion Date :||May 2019|
|Actual Study Completion Date :||May 2019|
Active Comparator: Screening
This arm includes all subjects randomized to regular dermatological follow-up visits on annual basis.
The screening visit consists in a general dermatological examination of the subject, with special focus on the onset of the following skin diseases during the follow-up period:
This arm includes all subjects randomized to the use of a tele-dermatology system for the evaluation of newly onset non-widespread skin lesions.
The system consists in a simple web-based/smartphone application through which subjects can send pictures of recently onset non-widespread skin lesions with special focus on the following diseases:
A dermatology will judge online pictures based on a standard scale. Each subject who will use the system will be also seen by routine clinical visit to confirm the online diagnosis. Subjects who will not send any picture will be seen for a dermatological examination at the end of each year.
- Cumulative incidence of at least one non-widespread skin lesion identified and clinically confirmed as suspected / highly suspected [ Time Frame: Two years ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02902822
|Local Health Authority (ATS)|
|Bergamo, Italy, 24121|
|Principal Investigator:||Luigi Naldi, MD||Centro Studi Gised|