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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06079619
Enrollment
157
Registered
2023-10-12
Start date
2022-03-01
Completion date
2022-04-20
Last updated
2024-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Genital Tumor, Pigmented Lesions

Keywords

dermoscopy, non-invasive imaging, melanotic macule, melanoses, mucosa, melanoma, vulva, glans, tumor, genital tumor, nevus

Brief 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.

Interventions

OTHERAnalysis 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.

Sponsors

Centre Hospitalier Universitaire de Saint Etienne
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Comparison results between expert dermatologists with x20 dermatoscopic photos (Group A) and non-dermatologists physicians with x400 dermatoscopic photos (Group B)Year: 1Performance of x400 dermatoscopic (results of expert dermatologists versus non-dermatologists physicians)

Secondary

MeasureTime frameDescription
Comparison results between expert dermatologists with x20 dermatoscopic photos (Group A) and gynecologists with x400 dermatoscopic photos (Group B1)Year: 1Performance of x400 dermatoscopic (results of expert dermatologists versus gynecologists)
Comparison results between expert dermatologists with x20 dermatoscopic photos (Group A) and general practitioners with x400 dermatoscopic photos (Group B2)Year: 1Performance of x400 dermatoscopic (results of expert dermatologists versus general practitioners)
Comparison results between gynecologists with x400 dermatoscopic photos (Group B1) and general practitioners with x400 dermatoscopic photos (Group B2).Year: 1Performance of x400 dermatoscopic (results of gynecologists versus general practitioners)
Comparison results between expert dermatologists with x400 dermatoscopic photos (Group A) and skin Artificial intelligence software with x400 dermatoscopic photos (Group C).Year: 1Performance of x400 dermatoscopic (results of expert dermatologists versus skin Artificial intelligence software)
Comparison results between dermatologists physicians with x400 dermatoscopic photos (Group B) and skin Artificial intelligence software with x400 dermatoscopic photos (Group C).Year: 1Performance of x400 dermatoscopic (results of dermatologists physicians versus skin Artificial intelligence software)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026