NCT03493724

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
205

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 13, 2018

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

March 9, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 10, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

April 10, 2018

Status Verified

February 1, 2018

Enrollment Period

5 months

First QC Date

March 9, 2018

Last Update Submit

April 9, 2018

Conditions

Outcome Measures

Primary Outcomes (2)

  • sensitivity, specificity, positive and negative predictive values globally

    evaluation of the diagnostic performance of the test

    through study completion, an average 6 months

  • sensitivity, specificity, positive and negative predictive values stratified

    stratified on the families of pathologies : infectious pathology, inflammatory dermatosis, allergology, wound, oncology

    through study completion, an average 6 months

Secondary Outcomes (1)

  • Calculation of Cohen's kappa concordance between dermatologists

    through study completion, an average 6 months

Interventions

to evaluate the diagnostic performance of the photographs made by Smartphone, during requests for emergency dermatological advice

Also known as: evaluation of photographs in dermatology

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU Nancy, hopitaux de Brabois

Nancy, Vandoeuvre Les Nancy, 54000, France

RECRUITING

MeSH Terms

Conditions

Dermatitis

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2018

First Posted

April 10, 2018

Study Start

February 13, 2018

Primary Completion

July 1, 2018

Study Completion

September 1, 2018

Last Updated

April 10, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations