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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-A00319-42 | Other Identifier | ANSM |
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| Name | Class |
|---|---|
| DAMAE Médical | OTHER |
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OCTAV is a medical device class I, not 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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OCTAV Patient | Experimental | 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) |
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| OCTAV Control group | Experimental | Control group (patients without skin cancer) will have a skin imaging with a new Microscopy Optical Coherence (OCTAV) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OCTAV Patient | Device | In vivo skin imaging performed by placing the tip of the OCTAV device directly in slight contact with the skin of the patient. |
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| 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 |
| 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 |
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FOR PATIENT
Inclusion Criteria:
Exclusion Criteria:
FOR CONTROL GROUP
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Luc PERROT, MD | Centre Hospitalier Universitaire de Saint Etienne | Principal Investigator |
| Cécile DUPONT, PhD | Damae Medical | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu de Saint Etienne | Saint-Etienne | 42000 | France |
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| ID | Term |
|---|---|
| D012878 | Skin Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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One group of patients One group of non skin cancer patients
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| OCTAV Control group | Device | In vivo skin imaging performed by placing the tip of the OCTAV device directly in slight contact with the skin of the patient. |
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