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Completed

NCT Number: NCT02902822

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

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.

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Key information

Conditions

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

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Local Health Authority (ATS)

Bergamo, 24121, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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:

  • 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).

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:

  • 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 outcomes

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

    Time frame: Two years

Secondary outcomes

  1. 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

  2. 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

  3. Proportion of subjects who have at least one anticipated follow-up visit (within the comparator arm).

    Time frame: Within the two years study period

  4. 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

Sponsors and collaborators

Lead sponsor

Centro Studi Gised

Other

Registry information

Official study 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)

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Sep 16, 2016
Registry last updated
May 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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