Interest of Photographs by Smartphone in Dermatology (PHOTODERM)

April 9, 2018 updated by: Central Hospital, Nancy, France

Interest of the Photographs by Smartphone During the Requests of Opinion Specialized in the Department of Dermatology of the CHRU of Nancy

To study the diagnostic performance of the images on the smartphone compare the result of the clinical examination, all the dermatoses combined and by family of pathology (inflammatory, wound, oncology, infectious, allergology), during urgent request requests in dermatology

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The study is conducted in the dermatology department, for a maximum duration of 6 months. We include patients who require dermatological advice and for whom their doctor sends us photographs.

Doctors contact us by telephone, describe the symptoms and send photographs according to the secure procedure.

Patients are admitted for consultation and the diagnosis by photography is compared with the clinical diagnosis

Study Type

Observational

Enrollment (Anticipated)

205

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

  • France
    • Vandoeuvre Les Nancy
      • Nancy, Vandoeuvre Les Nancy, France, 54000
        • Recruiting
        • CHRU Nancy, Hopitaux de Brabois
        • Contact:
        • Principal Investigator:
          • Anne claire Bursztejn

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Major patients presenting with dermatitis, requiring specialized advice in dermatology at the University Hospital of Nancy

Description

Inclusion Criteria:

  • For which our fellow doctors ask a dermatological opinion for diagnostic purposes, after clinical examination of the patient, in an emergency
  • After obtaining the oral consent by the requesting doctor then informing and signing a non-opposition form during the consultation at the University Hospital of Nancy
  • Affiliation to a social protection
  • Doctors must have signed and sent back an ethical charter, where they undertake to send the image via MSsante, then to erase the image of the smartphone

Exclusion Criteria:

  • Patients under the protection of justice, tutorship or curatorship
  • Doctors : lack of smartphone powerful enough to offer a quality image

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sensitivity, specificity, positive and negative predictive values globally
Time Frame: through study completion, an average 6 months
evaluation of the diagnostic performance of the test
through study completion, an average 6 months
sensitivity, specificity, positive and negative predictive values stratified
Time Frame: through study completion, an average 6 months
stratified on the families of pathologies : infectious pathology, inflammatory dermatosis, allergology, wound, oncology
through study completion, an average 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Calculation of Cohen's kappa concordance between dermatologists
Time Frame: through study completion, an average 6 months
assessment of interobserver diagnostic agreement
through study completion, an average 6 months

Collaborators and Investigators

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

Sponsor

Central Hospital, Nancy, France

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)

February 13, 2018

Primary Completion (Anticipated)

July 1, 2018

Study Completion (Anticipated)

September 1, 2018

Study Registration Dates

First Submitted

March 9, 2018

First Submitted That Met QC Criteria

April 9, 2018

First Posted (Actual)

April 10, 2018

Study Record Updates

Last Update Posted (Actual)

April 10, 2018

Last Update Submitted That Met QC Criteria

April 9, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-A02607-46

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

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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