Optical Spectroscopy for Skin Carcinomas' Surgical Management (SPECTROLIVE)
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.
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.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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-
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Metz、法国、57085
- CHR Metz Thionville
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
学习计划
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Patients - Suffering from carcinomatous or polymorphous skin
|
an optical fiber will be put in gentle contact with the patient's skin in order to acquire optical spectra
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Optical spectroscopy's diagnostic validity for the 4 histological classes discrimination
大体时间：day 1
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day 1
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Statistical significance degree of the discrimination by molecular profiling (transcriptomic characterization) between in situ carcinoma (ISC) and invasive carcinoma (InvC).
大体时间：day 1
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day 1
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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
大体时间：day 1
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day 1
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- 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.
大体时间：day 1
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day 1
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合作者和调查者
调查人员
- 首席研究员：Grégoire Khairallah、g.khairallah@chr-metz-thionville.fr
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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