Comparison of Dermatoscopy X400 Interpreted by 6 Non-dermatologists and an Artificial Intelligence Software Skin Artificial Intelligence Versus Dermatoscopy x 20

Centre Hospitalier Universitaire de Saint Etienne

Status: Completed

Conditions: Pigmented Lesions; Genital Tumor

Treatments: Other: Analysis of photos of pigmented tumours by the three groups

Study type: Observational

Funder types: Other

Identifiers

NCT06079619

IRBN252022/CHUSTE

Details and patient eligibility

About

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.

Full description

The hypothesis that motivates this work is that X400 dermatoscopy in the hands of non-experts would allow a fast increase in their diagnostic capacity by identifying the main genital pigmented tumor, namely melanosis, and thus improve the use of expert centers relieved of the care of benign tumors.

Enrollment: 157 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

157 participants in 3 patient groups

Group A: expert dermatologists

Description:

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.

Treatment:

Other: Analysis of photos of pigmented tumours by the three groups

Group B: non-dermatologists

Description:

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.

Treatment:

Other: Analysis of photos of pigmented tumours by the three groups

Group C: Artificial intelligence

Description:

Artificial intelligence: the skin Artificial intelligence software, a learning base will be provided, different from the evaluation base and the test base.

Treatment:

Other: Analysis of photos of pigmented tumours by the three groups