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NCT06079619

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

Completed Last updated 5 April 2024
What this trial tests

trial testing Analysis of photos of pigmented tumours by the three groups in Genital Tumor in 157 participants. Completed in 20 April 2022.

Timeline
1 March 2022
Primary endpoint
20 April 2022
20 April 2022

Quick facts

Lead sponsorCentre Hospitalier Universitaire de Saint Etienne
StatusCompleted
Study typeOBSERVATIONAL
Enrollment157
Start date1 March 2022
Primary completion20 April 2022
Estimated completion20 April 2022
Sites1 location across France

Drugs / interventions tested

Conditions studied

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Who can join

18 and older, any sex, with Genital Tumor or Pigmented Lesions. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Data sources for this page

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