Optical Coherence Microscopy in Dermato-oncology

Study Overview
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Brief Summary
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OCTAV is a medical device class I, CE marked, based on a new technique for high-resolution imager (cell) internal microstructures of all types of biological tissues in vivo or ex vivo, to a depth of penetration 800 .mu.m. It allows to explore the epidermis, the dermo-epidermal junction and middle dermis in a totally non-invasive (direct contact with the tissue without sampling).

Detailed Description
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At the coming of the patient in Dermatology for resection / biopsy of the tumor (usual practice), for the study, an image of the tumor will be performed with the OCTAV device (about 5 minutes) for the study. Then, according to usual practice, resection / biopsy will be performed. This study aims to validate the clinical relevance of this device to characterize the 3 main skin cancers and to obtain the necessary data for the implementation of future clinical trials.

Official Title
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In Vivo Imaging Innovation : Optical Coherence Microscopy in Dermato-oncology

Conditions
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Skin Cancer

Intervention / Treatment
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* Device: OCTAV Patient
* Device: OCTAV Control group


Participation Criteria
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Eligibility Criteria
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FOR PATIENT Inclusion Criteria: Patient with a cutaneous lesion suspicious for melanoma, basal cell carcinoma, squamous cell carcinoma, requiring a surgical excision Consent form signed Major patient Exclusion Criteria: Allergy or intolerance to immersion oil (used for microscopy) If female, pregnant or breast-feeding Patient unable to stand still for 60 seconds Skin lesions located near patient eyes (<3 cm) FOR CONTROL GROUP Inclusion Criteria: Aged between 18 to 40 years Consent form signed Patient of the dermatology department with non-pathological forearm skin Exclusion Criteria: Allergy or intolerance to immersion oil (used for microscopy) If female, pregnant or breast-feeding Patient unable to stand still for 60 seconds

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
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: One group of skin cancer patients One group without skin cancer patients
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OCTAV Patient<br>The patients who will have a biopsy of skin suspected to be a melanoma, basal cell carcinoma or squamous cell carcinoma will have a skin imaging with a new Microscopy Optical Coherence (OCTAV) | Device: OCTAV Patient<br>* In vivo skin imaging performed by placing the tip of the OCTAV device directly in slight contact with the skin of the patient.<br>* Other names: OCTAV, DAMAE Medical, Paris, France;|
| Experimental: OCTAV Control group<br>Control group (patients without skin cancer) will have a skin imaging with a new Microscopy Optical Coherence (OCTAV) | Device: OCTAV Control group<br>* In vivo skin imaging performed by placing the tip of the OCTAV device directly in slight contact with the skin of the patient.<br>* Other names: OCTAV, DAMAE Medical, Paris, France;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity | Sensitivity measures the proportion of positive skin cancers (according to the OCTAV device) that are correctly identified as such (according to gold standard : histology) | Day 1 | 
| Specificity | Specificity measures the proportion of negative skin cancers (according to the OCTAV device) that are correctly identified as such (according to gold standard : histology) | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of the thickness of the different skin layers (mm) | Only for the non skin cancer group. Theses measures will identify the different skin layers (Epidermis, Dermis, Subcutaneous tissue, Cross-section) | Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Optical biopsy, Skin cancer, Diagnostic performance