DermatitisPHOTODERMNCT03493724
Interest of Photographs by Smartphone in Dermatology
An observational study of Dermatitis, run by Central Hospital, Nancy, France at 1 site in France.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dermatitis
- What is being tested?
- telemedecine
- How many people
- 205 participants
- Where
- 1 siteFrance
- Study dates
- 13 Feb 2018to 1 Sep 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Major patients presenting with dermatitis, requiring specialized advice in dermatology at the University Hospital of Nancy
Who may be able to join
- 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
Who cannot join
- Patients under the protection of justice, tutorship or curatorship
- Doctors : lack of smartphone powerful enough to offer a quality image
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHRU Nancy, hopitaux de Brabois
Nancy, Vandoeuvre Les Nancy, 54000
JULIE HENRY, à673568683, henryjulie@outlook.fr
Anne claire Bursztejn
About this study
Official title: 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
Read the 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
- Conditions
- Dermatitis
- Being tested
- telemedecine
- Medical subject headings
- Dermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
telemedecineOther
Also called evaluation of photographs in dermatology
to evaluate the diagnostic performance of the photographs made by Smartphone, during requests for emergency dermatological advice
What is being measured
The primary outcome is the main question the study is designed to answer.
sensitivity, specificity, positive and negative predictive values globally
evaluation of the diagnostic performance of the test
Measured: 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
Measured: through study completion, an average 6 months
Secondary outcomes (1)
Calculation of Cohen's kappa concordance between dermatologists
assessment of interobserver diagnostic agreement
Measured: through study completion, an average 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2018
- Study start13 Feb 2018
- Primary completion1 Jul 2018 (estimated)
- Study completion1 Sep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DermatitisStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 205 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03493724
- Sponsor's protocol ID
- 2017-A02607-46
- Acronym
- PHOTODERM
- Status last verified
- Feb 2018
- First submitted
- 9 Mar 2018
- Last updated
- 10 Apr 2018
- Results posted
- No
- FDA-regulated drug
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of the Photographs by Smartphone During the Requests of Opinion Specialized in the Department of Dermatology of the CHRU of Nancy
- ClinicalTrials.gov ID
- NCT03493724
- Acronym / sponsor ID
- PHOTODERM / 2017-A02607-46
- Conditions
- Dermatitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 205 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 13 Feb 2018 (actual)
- Primary completion
- 1 Jul 2018 (estimated)
- Study completion
- 1 Sep 2018 (estimated)
- First posted
- 10 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Major patients presenting with dermatitis, requiring specialized advice in dermatology at the University Hospital of Nancy
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Patients under the protection of justice, tutorship or curatorship
- Doctors : lack of smartphone powerful enough to offer a quality image
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| telemedecineAlso: evaluation of photographs in dermatologyto evaluate the diagnostic performance of the photographs made by Smartphone, during requests for emergency dermatological advice | Other | – |
Primary outcome
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
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
1 secondary outcome
Calculation of Cohen's kappa concordance between dermatologists
Time frame: through study completion, an average 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dermatitis, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sensitivity, specificity, positive and negative predictive values globally (time frame: through study completion, an average 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2018.