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临床试验/NCT06079619
NCT06079619已完成不适用

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?

Centre Hospitalier Universitaire de Saint Etienne1 个研究点 分布在 1 个国家目标入组 157 人开始时间: 2022年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
157
试验地点
1
主要终点
Comparison results between expert dermatologists with x20 dermatoscopic photos (Group A) and non-dermatologists physicians with x400 dermatoscopic photos (Group B)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 未提供

结局指标

主要结局

Comparison results between expert dermatologists with x20 dermatoscopic photos (Group A) and non-dermatologists physicians with x400 dermatoscopic photos (Group B)

时间窗: Year: 1

Performance of x400 dermatoscopic (results of expert dermatologists versus non-dermatologists physicians)

次要结局

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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