Skin Cancer
Conditions
Keywords
Optical biopsy, Skin cancer, Diagnostic performance
Brief summary
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).
Detailed description
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.
Interventions
DEVICEOCTAV Patient
In vivo skin imaging performed by placing the tip of the OCTAV device directly in slight contact with the skin of the patient.
DEVICEOCTAV Control group
In vivo skin imaging performed by placing the tip of the OCTAV device directly in slight contact with the skin of the patient.
Sponsors
Centre Hospitalier Universitaire de Saint Etienne
DAMAE Médical
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
One group of patients One group of non skin cancer patients
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity | Day 1 | Sensitivity measures the proportion of positive skin cancers (according to the OCTAV device) that are correctly identified as such (according to gold standard : histology) |
| Specificity | Day 1 | Specificity measures the proportion of negative skin cancers (according to the OCTAV device) that are correctly identified as such (according to gold standard : histology) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measure of the thickness of the different skin layers (mm) | Day 1 | Only for the non skin cancer group. Theses measures will identify the different skin layers (Epidermis, Dermis, Subcutaneous tissue, Cross-section) |
Countries
France
Outcome results
None listed