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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Screening | Active Comparator | This arm includes all subjects randomized to regular dermatological follow-up visits on annual basis. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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:
|
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative incidence of at least one non-widespread skin lesion identified and clinically confirmed as suspected / highly suspected | Two years |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Luigi Naldi, MD | Centro Studi Gised | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Health Authority (ATS) | Bergamo | 24121 | Italy |
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|
| 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:
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. |
|
| 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 |
| ID | Term |
|---|---|
| D004886 | Erysipelas |
| D007169 | Impetigo |
| D006562 | Herpes Zoster |
| D008976 | Molluscum Contagiosum |
| D014860 | Warts |
| D014005 | Tinea |
| D008545 | Melanoma |
| D055623 | Keratosis, Actinic |
| D002280 | Carcinoma, Basal Cell |
| D002294 | Carcinoma, Squamous Cell |
| D009506 | Nevus |
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D013290 | Streptococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D017192 | Skin Diseases, Bacterial |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D013207 | Staphylococcal Skin Infections |
| D013203 | Staphylococcal Infections |
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D011213 | Poxviridae Infections |
| D017193 | Skin Diseases, Viral |
| D030361 | Papillomavirus Infections |
| D014412 | Tumor Virus Infections |
| D003881 | Dermatomycoses |
| D009181 | Mycoses |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D011230 | Precancerous Conditions |
| D007642 | Keratosis |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D018295 | Neoplasms, Basal Cell |
| D018307 | Neoplasms, Squamous Cell |
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D008403 | Mass Screening |
| ID | Term |
|---|---|
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006306 | Health Surveys |
| D011795 | Surveys and Questionnaires |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D003954 | Diagnostic Services |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D015980 | Public Health Practice |
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