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

May 16, 2019 updated by: Centro Studi Gised

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

461

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bergamo, Italy, 24121
        • Local Health Authority (ATS)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cumulative incidence of at least one non-widespread skin lesion identified and clinically confirmed as suspected / highly suspected
Time Frame: Two years
Two years

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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).
Time Frame: Within the two years study period
Within the two years study period
Proportion of subjects who have at least one anticipated follow-up visit (within the comparator arm).
Time Frame: Within the two years study period
Within the two years study period
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
Within the two years study period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centro Studi Gised

Investigators

  • Principal Investigator: Luigi Naldi, MD, Centro Studi Gised

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2016

Primary Completion (Actual)

May 1, 2019

Study Completion (Actual)

May 1, 2019

Study Registration Dates

First Submitted

September 8, 2016

First Submitted That Met QC Criteria

September 12, 2016

First Posted (Estimate)

September 16, 2016

Study Record Updates

Last Update Posted (Actual)

May 17, 2019

Last Update Submitted That Met QC Criteria

May 16, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLICCAILNEO_2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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