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

NCT02902822 | Completed

• 1 other identifier: CLICCAILNEO_2
• Study Type: interventional
• Target: 461
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Cumulative incidence of at least one non-widespread skin lesion identified and clinically confirmed as suspected / highly suspected

  Two years

Secondary Outcomes (4)

• 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 who have at least one anticipated follow-up visit (within the comparator 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

Study Arms (2)

Screening

ACTIVE COMPARATOR

This arm includes all subjects randomized to regular dermatological follow-up visits on annual basis.

Procedure: Screening

Tele-dermatology

EXPERIMENTAL

This arm includes all subjects randomized to the use of a tele-dermatology system for the evaluation of newly onset non-widespread skin lesions.

Device: Tele-dermatology

Interventions

Screening PROCEDURE

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).

Screening

Tele-dermatology DEVICE

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.

Tele-dermatology

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects currently working at the Local Health Authority of the province of Bergamo

You may not qualify if:

• Subjects who are not able to use the tele-dermatology system or who have no access to the website or the specific app.

Sponsors & Collaborators

• Centro Studi Gised: lead

Study Sites (1)

Local Health Authority (ATS)

Bergamo, 24121, Italy

Location

MeSH Terms

Conditions

Erysipelas; Impetigo; Herpes Zoster; Molluscum Contagiosum; Warts; Tinea; Melanoma; Keratosis, Actinic; Carcinoma, Basal Cell; Carcinoma, Squamous Cell; Nevus; Alzheimer Disease

Interventions

Mass Screening

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Bacterial; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases; Staphylococcal Skin Infections; Staphylococcal Infections; Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Poxviridae Infections; Skin Diseases, Viral; Papillomavirus Infections; Tumor Virus Infections; Dermatomycoses; Mycoses; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Precancerous Conditions; Keratosis; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Basal Cell; Neoplasms, Squamous Cell; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice

Study Officials

• Luigi Naldi, MD

  Centro Studi Gised

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2016
• First Posted: September 16, 2016
• Study Start: October 1, 2016
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: May 17, 2019

Record last verified: 2019-05

Locations

IT (1)