NCT02902822

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

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)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 461 (actual)
• Sponsor: Centro Studi Gised · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
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: 1. bacterial skin infections - pyoderma - or viral (erysipelas, impetigo, herpes zoster, molluscum contagiosum, viral warts); 2. fungal skin infections (tinea corporis, cruris, pedis); 3. pigmented tumors (melanoma); 4. 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: 1. bacterial skin infections - pyoderma - or viral (erysipelas, impetigo, herpes zoster, molluscum contagiosum, viral warts); 2. fungal skin infections (tinea corporis, cruris, pedis); 3. pigmented tumors (melanoma); 4. 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.

Timeline

• Start date: 2016-10-01
• Primary completion: 2019-05-01
• Completion: 2019-05-01
• First posted: 2016-09-16
• Last updated: 2019-05-17

Locations

1 site across 1 country: Italy