NCT06079619

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?

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 157 (actual)
• Sponsor: Centre Hospitalier Universitaire de Saint Etienne · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Genital Tumor
• Pigmented Lesions

Interventions

Type	Name	Description
OTHER	Analysis of photos of pigmented tumours by the three groups	Analysis of photos of pigmented tumours by the three groups with different techniques for each group to compare them.

Timeline

• Start date: 2022-03-01
• Primary completion: 2022-04-20
• Completion: 2022-04-20
• First posted: 2023-10-12
• Last updated: 2024-04-05

Locations

1 site across 1 country: France