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

Study Overview
=================
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.

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)

Conditions
-----------------
Erysipelas, Impetigo, Herpes Zoster, Molluscum Contagiosum, Warts, Tinea, Melanoma, Actinic Keratosis, Basal Cell Carcinoma, Squamous Cell Carcinoma

Intervention / Treatment
-----------------
* Procedure: Screening
* Device: Tele-dermatology


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects currently working at the Local Health Authority of the province of Bergamo Exclusion Criteria: Subjects who are not able to use the tele-dermatology system or who have no access to the website or the specific app.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Screening<br>This arm includes all subjects randomized to regular dermatological follow-up visits on annual basis. | Procedure: Screening<br>* 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: bacterial skin infections - pyoderma - or viral (erysipelas, impetigo, herpes zoster, molluscum contagiosum, viral warts); fungal skin infections (tinea corporis, cruris, pedis); pigmented tumors (melanoma); non-melanocytic tumors (actinic keratoses, basal cell or squamous cell carcinoma).<br>|
| Experimental: Tele-dermatology<br>This arm includes all subjects randomized to the use of a tele-dermatology system for the evaluation of newly onset non-widespread skin lesions. | Device: Tele-dermatology<br>* 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: bacterial skin infections - pyoderma - or viral (erysipelas, impetigo, herpes zoster, molluscum contagiosum, viral warts); fungal skin infections (tinea corporis, cruris, pedis); pigmented tumors (melanoma); non-melanocytic tumors (actinic keratoses, basal cell or squamous cell carcinoma). 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative incidence of at least one non-widespread skin lesion identified and clinically confirmed as suspected / highly suspected |  | Two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 who have at least one anticipated follow-up visit (within the comparator 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
melanoma, non-melanoma skin cancer, mole, app, cliccailneo