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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE September 8, 2016
First Posted Date  ICMJE September 16, 2016
Last Update Posted Date May 17, 2019
Actual Study Start Date  ICMJE October 2016
Actual Primary Completion Date May 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 12, 2016)
Cumulative incidence of at least one non-widespread skin lesion identified and clinically confirmed as suspected / highly suspected [ Time Frame: Two years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2016)
  • 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 ]
  • 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 ]
  • Proportion of subjects who have at least one anticipated follow-up visit (within the comparator arm). [ Time Frame: 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tele-dermatology of Skin Cancer in a Cohort of Local Health Authority Employees in the Province of Bergamo
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Erysipelas
  • Impetigo
  • Herpes Zoster
  • Molluscum Contagiosum
  • Warts
  • Tinea
  • Melanoma
  • Actinic Keratosis
  • Basal Cell Carcinoma
  • Squamous Cell Carcinoma
Intervention  ICMJE
  • 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).
  • 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.

Study Arms  ICMJE
  • Active Comparator: Screening
    This arm includes all subjects randomized to regular dermatological follow-up visits on annual basis.
    Intervention: Procedure: Screening
  • 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.
    Intervention: Device: Tele-dermatology
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 16, 2019)
461
Original Estimated Enrollment  ICMJE
 (submitted: September 12, 2016)
500
Actual Study Completion Date  ICMJE May 2019
Actual Primary Completion Date May 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02902822
Other Study ID Numbers  ICMJE CLICCAILNEO_2
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Centro Studi Gised
Study Sponsor  ICMJE Centro Studi Gised
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Luigi Naldi, MD Centro Studi Gised
PRS Account Centro Studi Gised
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP