Optical Spectroscopy for Skin Carcinomas' Surgical Management

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Carcinomatous or Polymorphous Skin Lesions

Intervention / Treatment
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* Device: bimodal optical spectroscopy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients - Suffering from carcinomatous or polymorphous skin<br> | Device: bimodal optical spectroscopy<br>* an optical fiber will be put in gentle contact with the patient's skin in order to acquire optical spectra<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Optical spectroscopy's diagnostic validity for the 4 histological classes discrimination |  | day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |