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

Melanoma Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02902822
• Other study ID #: CLICCAILNEO_2
• Status: Completed
• Phase: N/A
• Start date: October 2016
• Est. completion date: May 2019

Study information

• Verified date: May 2019
• Source: Centro Studi Gised
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 461
• Est. completion date: May 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Actinic Keratosis
• Basal Cell Carcinoma
• Carcinoma
• Carcinoma, Basal Cell
• Carcinoma, Squamous Cell
• Erysipelas
• Herpes Zoster
• Impetigo
• Keratosis
• Keratosis, Actinic
• Melanoma
• Molluscum Contagiosum
• Skin Neoplasms
• Squamous Cell Carcinoma
• Tinea
• Warts

Intervention

Procedure:
• Screening
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).

Device:
• Tele-dermatology
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.

Locations

Country	Name	City	State
Italy	Local Health Authority (ATS)	Bergamo

Sponsors (1)

Lead Sponsor	Collaborator
Centro Studi Gised

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative incidence of at least one non-widespread skin lesion identified and clinically confirmed as suspected / highly suspected		Two years
Secondary	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
Secondary	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
Secondary	Proportion of subjects who have at least one anticipated follow-up visit (within the comparator arm).		Within the two years study period
Secondary	Proportion of subjects with at least one missed scheduled visit at follow-up(within the comparator arm).		Within the two years study period