Tele-dermatology of Skin Cancer in a Cohort of Local Health Authority Employees in the Province of Bergamo
Primary Purpose
Erysipelas, Impetigo, Herpes Zoster
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Screening
Tele-dermatology
Sponsored by
About this trial
This is an interventional diagnostic trial for Erysipelas focused on measuring melanoma, non-melanoma skin cancer, mole, app, cliccailneo
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.
Sites / Locations
- Local Health Authority (ATS)
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Screening
Tele-dermatology
Arm Description
This arm includes all subjects randomized to regular dermatological follow-up visits on annual basis.
This arm includes all subjects randomized to the use of a tele-dermatology system for the evaluation of newly onset non-widespread skin lesions.
Outcomes
Primary Outcome Measures
Cumulative incidence of at least one non-widespread skin lesion identified and clinically confirmed as suspected / highly suspected
Secondary Outcome Measures
Agreement between the tele-dermatology system and the direct dermatological visit as assessed by Cohen's kappa (within the experimental arm).
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).
Proportion of subjects who have at least one anticipated follow-up visit (within the comparator arm).
Proportion of subjects with at least one missed scheduled visit at follow-up(within the comparator arm).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02902822
Brief Title
Tele-dermatology of Skin Cancer in a Cohort of Local Health Authority Employees in the Province of Bergamo
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)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
October 2016 (Actual)
Primary Completion Date
May 2019 (Actual)
Study Completion Date
May 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centro Studi Gised
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erysipelas, Impetigo, Herpes Zoster, Molluscum Contagiosum, Warts, Tinea, Melanoma, Actinic Keratosis, Basal Cell Carcinoma, Squamous Cell Carcinoma
Keywords
melanoma, non-melanoma skin cancer, mole, app, cliccailneo
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
461 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Screening
Arm Type
Active Comparator
Arm Description
This arm includes all subjects randomized to regular dermatological follow-up visits on annual basis.
Arm Title
Tele-dermatology
Arm Type
Experimental
Arm Description
This arm includes all subjects randomized to the use of a tele-dermatology system for the evaluation of newly onset non-widespread skin lesions.
Intervention Type
Procedure
Intervention Name(s)
Screening
Intervention Description
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).
Intervention Type
Device
Intervention Name(s)
Tele-dermatology
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cumulative incidence of at least one non-widespread skin lesion identified and clinically confirmed as suspected / highly suspected
Time Frame
Two years
Secondary Outcome Measure Information:
Title
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
Title
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
Title
Proportion of subjects who have at least one anticipated follow-up visit (within the comparator arm).
Time Frame
Within the two years study period
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luigi Naldi, MD
Organizational Affiliation
Centro Studi Gised
Official's Role
Principal Investigator
Facility Information:
Facility Name
Local Health Authority (ATS)
City
Bergamo
ZIP/Postal Code
24121
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Tele-dermatology of Skin Cancer in a Cohort of Local Health Authority Employees in the Province of Bergamo
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