Comparison of Dermatoscopy X400 Interpreted by 6 Non-dermatologists and an Artificial Intelligence Software Skin Artificial Intelligence Versus Dermatoscopy x 20
Comparison of Dermatoscopy X400 Interpreted by 6 Non-dermatologists (3 Gynecologists, 3 General Practitioners) and an Artificial Intelligence Software Skin Artificial Intelligence Versus Dermatoscopy x 20 Interpreted by 3 Expert Dermatologists, for the Identification of 150 Genital Pigmented Tumors: Towards a New Medical Organization of the Dermatologist, Non-dermatologist Articulation?
Pigmented lesions of the genital mucosa are common, affecting between 10% and 20% of the population. The clinical appearance is sometimes confusing. They are often extensive, irregular, and inhomogeneous in color, which can make them look suspicious. Moreover, dermatoscopic imaging is often complex to interpret, as shown by the many different patterns reported in the literature.
Thus, preliminary work in confocal microscopy has shown that it is possible to simplify diagnosis by using microscopic, in vivo, non-invasive imaging. However, CIM cameras are rare, very expensive and difficult to access.
Conversely, digital dermatoscopes with 400x magnification are much less expensive and can also allow, in a certain number of cases, an examination at the cellular level of tumors, with, in our opinion, the advantage of being easy to learn. In the context of the pooling of resources within medical centers in particular, their dissemination should accelerate. Furthermore, x400 dermatoscopy can provide similar information to IVCM for the most frequent black genital tumors.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Saint-Étienne, France
- CHU Saint Etienne
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Men and women with a pigmented lesion of the genital mucosa, having benefited from a mucosal consultation at the University Hospital of Saint-Etienne, with Professor Perrot.
- The patient's clinical file must contain clinical images, dermatoscopy images x 20 and at least 1 dermatoscopy image x 400.
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Group A: expert dermatologists
Group A is composed of expert dermatologists. Group A doctors will have at their disposal 150 dermoscopic photos, x20 dermatoscopic photos according to the usual practice of pigmented genital tumors. The dermatologists will characterize the dermatoscopy with a standardized reading grid to assess the different dermatoscopic patterns of genital tumors. |
Analysis of photos of pigmented tumours by the three groups with different techniques for each group to compare them.
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Group B: non-dermatologists
Group B is composed of gynecologists (Group B1) and general practitioners (B2) Group B physicians will only perform dermatoscopy x 400. They will have been given a maximum of 1 hour's training to identify melanosis-type pigmented tumors, which are the most frequent benign tumors in x 400 dermatoscopy. Only three x400 dermatoscopy patterns will be presented to them to the exclusion of all others, which are sufficient to identify benign lesions. |
Analysis of photos of pigmented tumours by the three groups with different techniques for each group to compare them.
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Group C: Artificial intelligence
Artificial intelligence: the skin Artificial intelligence software, a learning base will be provided, different from the evaluation base and the test base.
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Analysis of photos of pigmented tumours by the three groups with different techniques for each group to compare them.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Comparison results between expert dermatologists with x20 dermatoscopic photos (Group A) and non-dermatologists physicians with x400 dermatoscopic photos (Group B)
Time Frame: Year: 1
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Performance of x400 dermatoscopic (results of expert dermatologists versus non-dermatologists physicians)
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Year: 1
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Comparison results between expert dermatologists with x20 dermatoscopic photos (Group A) and gynecologists with x400 dermatoscopic photos (Group B1)
Time Frame: Year: 1
|
Performance of x400 dermatoscopic (results of expert dermatologists versus gynecologists)
|
Year: 1
|
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Comparison results between expert dermatologists with x20 dermatoscopic photos (Group A) and general practitioners with x400 dermatoscopic photos (Group B2)
Time Frame: Year: 1
|
Performance of x400 dermatoscopic (results of expert dermatologists versus general practitioners)
|
Year: 1
|
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Comparison results between gynecologists with x400 dermatoscopic photos (Group B1) and general practitioners with x400 dermatoscopic photos (Group B2).
Time Frame: Year: 1
|
Performance of x400 dermatoscopic (results of gynecologists versus general practitioners)
|
Year: 1
|
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Comparison results between expert dermatologists with x400 dermatoscopic photos (Group A) and skin Artificial intelligence software with x400 dermatoscopic photos (Group C).
Time Frame: Year: 1
|
Performance of x400 dermatoscopic (results of expert dermatologists versus skin Artificial intelligence software)
|
Year: 1
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Comparison results between dermatologists physicians with x400 dermatoscopic photos (Group B) and skin Artificial intelligence software with x400 dermatoscopic photos (Group C).
Time Frame: Year: 1
|
Performance of x400 dermatoscopic (results of dermatologists physicians versus skin Artificial intelligence software)
|
Year: 1
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jean Luc Perrot, MD PhD, CHU Saint Etienne
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IRBN252022/CHUSTE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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