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

Sponsor

Centre Hospitalier Universitaire de Saint Etienne (Other)

Overall Status

Completed

CT.gov ID

NCT06079619

Collaborator

(none)

157

Enrollment

Location

1.6

Actual Duration (Months)

95.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Genital Tumor Pigmented Lesions	Other: Analysis of photos of pigmented tumours by the three groups

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.

Study Design

Study Type:

Observational

Actual Enrollment :

157 participants

Observational Model:

Case-Control

Time Perspective:

Retrospective

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?

Actual Study Start Date :

Mar 1, 2022

Actual Primary Completion Date :

Apr 20, 2022

Actual Study Completion Date :

Apr 20, 2022

Arms and Interventions

Arm	Intervention/Treatment
Group A: expert dermatologists 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.	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.
Group B: non-dermatologists 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.	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.
Group C: Artificial intelligence Artificial intelligence: the skin Artificial intelligence software, a learning base will be provided, different from the evaluation base and the test base.	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.

Arm

Intervention/Treatment

Group A: expert dermatologists

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.

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.

Group B: non-dermatologists

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.

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.

Group C: Artificial intelligence

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

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Performance of x400 dermatoscopic (results of expert dermatologists versus gynecologists) [Year: 1]
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 general practitioners) [Year: 1]
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 gynecologists versus general practitioners) [Year: 1]
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 expert dermatologists versus skin Artificial intelligence software) [Year: 1]
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 dermatologists physicians versus skin Artificial intelligence software) [Year: 1]
Comparison results between dermatologists physicians with x400 dermatoscopic photos (Group B) and skin Artificial intelligence software with x400 dermatoscopic photos (Group C).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.