Assessment of Optical Spectroscopy's Diagnosis Accuracy When Non-invasively and Automatically Classifying Skin Lesions in One of the Following Histological Classes: Healthy, Actinic Keratosis, in Situ Carcinoma and Invasive Carcinoma.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 142
- 试验地点
- 2
- 主要终点
- Optical spectroscopy's diagnostic validity for the 4 histological classes discrimination
研究概览
简要总结
Actinic keratosis are of utmost medical and economical interest because of their high prevalence (20 % of 60 year-old people and older in the Northern hemisphere) and their important cosmetic impact as such actinic keratosis mostly appear on photo-exposed skin sites. The surgeon in charge of such lesions' removal (i) some actinic keratosis adjoining carcinoma to be resected therefore causing the problem of functional areas damaging (eyelids, lips, etc.) or (ii) numerous actinic keratosis localized away from carcinoma (photo-carcinogenesis field) faces the issue of clinical evaluation of such lesions: which ones will spontaneously regress (it is supposed to be the case for 20 % of such lesions);which ones will remain and which ones will develop into invasive carcinomas ?
A non-invasive, non-traumatic, automated and real-time help for the clinical diagnosis orientation of such skin lesions could help improving diagnosis accuracy of the medical practitioner's visual inspection:
- In terms of sensitivity in order to potentially decrease the number of actinic keratosis evolving towards invasive carcinoma,
- In terms of specificity in order to potentially decrease useless resections and reduce resection margins and therefore reduce scars surface.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults, and
- •Autonomous: enjoying full citizenship rights and full mental abilities, and
- •Affiliated to a social security system, and
- •Suffering from carcinomatous or polymorphous skin lesions that can be fully managed in an outpatient (ambulatory) surgery procedure.
排除标准
- •Carcinomatous or polymorphous skin lesions that require day admission, or
- •Carcinomatous or polymorphous skin lesions for which resection margins are uncertain, or
- •Naevomatous skin lesions and related skin pathologies.
研究组 & 干预措施
Patients - Suffering from carcinomatous or polymorphous skin
干预措施: bimodal optical spectroscopy (Device)
结局指标
主要结局
Optical spectroscopy's diagnostic validity for the 4 histological classes discrimination
时间窗: day 1
次要结局
- Statistical significance degree of the discrimination by molecular profiling (transcriptomic characterization) between in situ carcinoma (ISC) and invasive carcinoma (InvC).(day 1)
- Statistical significance degree of the discrimination by molecular profiling (transcriptomic characterization) between 2 classes of actinic keratosis (AK) of clinical relevance: AK characterized by a "low" versus a "high" invasiveness risk(day 1)
- - Sensitivity and specificity of optical spectroscopy for discriminating the é molecular classes of actinic keratosis: AK characterized by a "low" versus a "high" invasiveness risk.(day 1)