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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02902822
• Date of registration: 08/09/2016
• Prospective Registration: Yes
• Primary sponsor: Centro Studi Gised
• Public title: Tele-dermatology of Skin Cancer in a Cohort of Local Health Authority Employees in the Province of Bergamo
• Scientific 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)
• Date of first enrolment: October 2016
• Target sample size: 461
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02902822
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Italy

Contacts

• Name: Luigi Naldi, MD
• Affiliation: Centro Studi Gised

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 99 Years
Gender: All

Health Condition(s) or Problem(s) studied

Herpes Zoster

Impetigo

Warts

Basal Cell Carcinoma

Actinic Keratosis

Tinea

Erysipelas

Melanoma

Molluscum Contagiosum

Squamous Cell Carcinoma

Intervention(s)

Device: Tele-dermatology

Procedure: Screening

Primary Outcome(s)

Cumulative incidence of at least one non-widespread skin lesion identified and clinically confirmed as suspected / highly suspected [Time Frame: Two years]

Secondary Outcome(s)

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]

Secondary ID(s)

CLICCAILNEO_2

Source(s) of Monetary Support

Please refer to primary and secondary sponsors