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

NCT ID: NCT02902822

Last Updated: 2019-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

461 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2019-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Erysipelas Impetigo Herpes Zoster Molluscum Contagiosum Warts Tinea Melanoma Actinic Keratosis Basal Cell Carcinoma Squamous Cell Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Screening

This arm includes all subjects randomized to regular dermatological follow-up visits on annual basis.

Group Type ACTIVE_COMPARATOR

Screening

Intervention Type 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:

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).

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.

Group Type EXPERIMENTAL

Tele-dermatology

Intervention Type 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:

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.

Interventions

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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).

Intervention Type PROCEDURE

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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centro Studi Gised

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Luigi Naldi, MD

Role: PRINCIPAL_INVESTIGATOR

Centro Studi Gised

Locations

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Local Health Authority (ATS)

Bergamo, , Italy

Site Status

Countries

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Italy

Other Identifiers

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CLICCAILNEO_2

Identifier Type: -

Identifier Source: org_study_id

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