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

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ClinicalTrials.gov Identifier: NCT02902822
Recruitment Status : Completed
First Posted : September 16, 2016
Last Update Posted : May 17, 2019
Sponsor:
Information provided by (Responsible Party):
Centro Studi Gised

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.

Condition or disease Intervention/treatment Phase
Erysipelas Impetigo Herpes Zoster Molluscum Contagiosum Warts Tinea Melanoma Actinic Keratosis Basal Cell Carcinoma Squamous Cell Carcinoma Procedure: Screening Device: Tele-dermatology Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 461 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official 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)
Actual Study Start Date : October 2016
Actual Primary Completion Date : May 2019
Actual Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Skin Cancer

Arm Intervention/treatment
Active Comparator: Screening
This arm includes all subjects randomized to regular dermatological follow-up visits on annual basis.
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).

Experimental: Tele-dermatology
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

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.





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

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02902822


Locations
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Italy
Local Health Authority (ATS)
Bergamo, Italy, 24121
Sponsors and Collaborators
Centro Studi Gised
Investigators
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Principal Investigator: Luigi Naldi, MD Centro Studi Gised

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Responsible Party: Centro Studi Gised
ClinicalTrials.gov Identifier: NCT02902822     History of Changes
Other Study ID Numbers: CLICCAILNEO_2
First Posted: September 16, 2016    Key Record Dates
Last Update Posted: May 17, 2019
Last Verified: May 2019

Keywords provided by Centro Studi Gised:
melanoma
non-melanoma skin cancer
mole
app
cliccailneo

Additional relevant MeSH terms:
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Carcinoma
Melanoma
Carcinoma, Squamous Cell
Keratosis
Keratosis, Actinic
Carcinoma, Basal Cell
Skin Neoplasms
Herpes Zoster
Impetigo
Molluscum Contagiosum
Erysipelas
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplasms, Squamous Cell
Skin Diseases
Precancerous Conditions
Neoplasms, Basal Cell
Neoplasms by Site
Varicella Zoster Virus Infection
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Staphylococcal Skin Infections
Staphylococcal Infections