Pigmented Lesions Clinical Trial
Official title:
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?
Verified date | September 2023 |
Source | Centre Hospitalier Universitaire de Saint Etienne |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 157 |
Est. completion date | April 20, 2022 |
Est. primary completion date | April 20, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | CHU Saint Etienne | Saint-Étienne |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire de Saint Etienne |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Comparison results between expert dermatologists with x20 dermatoscopic photos (Group A) and non-dermatologists physicians with x400 dermatoscopic photos (Group B) | Performance of x400 dermatoscopic (results of expert dermatologists versus non-dermatologists physicians) | Year: 1 | |
Secondary | Comparison results between expert dermatologists with x20 dermatoscopic photos (Group A) and gynecologists with x400 dermatoscopic photos (Group B1) | Performance of x400 dermatoscopic (results of expert dermatologists versus gynecologists) | Year: 1 | |
Secondary | Comparison results between expert dermatologists with x20 dermatoscopic photos (Group A) and general practitioners with x400 dermatoscopic photos (Group B2) | Performance of x400 dermatoscopic (results of expert dermatologists versus general practitioners) | Year: 1 | |
Secondary | Comparison results between gynecologists with x400 dermatoscopic photos (Group B1) and general practitioners with x400 dermatoscopic photos (Group B2). | Performance of x400 dermatoscopic (results of gynecologists versus general practitioners) | Year: 1 | |
Secondary | Comparison results between expert dermatologists with x400 dermatoscopic photos (Group A) and skin Artificial intelligence software with x400 dermatoscopic photos (Group C). | Performance of x400 dermatoscopic (results of expert dermatologists versus skin Artificial intelligence software) | Year: 1 | |
Secondary | Comparison results between dermatologists physicians with x400 dermatoscopic photos (Group B) and skin Artificial intelligence software with x400 dermatoscopic photos (Group C). | Performance of x400 dermatoscopic (results of dermatologists physicians versus skin Artificial intelligence software) | Year: 1 |
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