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

Not Applicable

Completed

• Conditions: Melanoma; Basal Cell Carcinoma; Erysipelas; Impetigo; Herpes Zoster; Warts; Tinea; Squamous Cell Carcinoma; Molluscum Contagiosum; Actinic Keratosis
• Interventions: Procedure: Screening; Device: Tele-dermatology

• Registration Number: NCT02902822
• Lead Sponsor: Centro Studi Gised

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 Description

Not available

Study Timeline

• Study First Submitted: 2016-09-08
• Study First Submitted QC: 2016-09-12
• Study First Posted: 2016-09-16
• Study Start: 2016-10
• Status Verified: 2019-05
• Primary Completion: 2019-05
• Study Completion: 2019-05
• Last Update Submitted: 2019-05-16
• Last Update Posted: 2019-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 461

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Screening	Screening	This arm includes all subjects randomized to regular dermatological follow-up visits on annual basis.
Tele-dermatology	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.

Primary Outcome Measures

Name	Time	Method
Cumulative incidence of at least one non-widespread skin lesion identified and clinically confirmed as suspected / highly suspected	Two years

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Local Health Authority (ATS); 🇮🇹 Bergamo, Italy