An interventional study of OCTAV Patient and OCTAV Control group in Skin Cancer, sponsored by Centre Hospitalier Universitaire de Saint Etienne. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-12-07.
Sponsored by Centre Hospitalier Universitaire de Saint Etienne · Not applicable, Interventional, and Diagnostic
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).
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.
582 studies on the registry are indexed under Skin Neoplasms; 114 are open to participants now.
This study's enrollment of 273 is above the median of 53 across 416 interventional studies indexed under Skin Neoplasms.
Browse Skin Neoplasms studies →Centre Hospitalier Universitaire de Saint Etienne is the lead sponsor of 578 studies on the registry; 128 are open to participants now.
Counted across the registry records on this site, refreshed daily.
FOR PATIENT
Inclusion Criteria:
Exclusion Criteria:
FOR CONTROL GROUP
Inclusion Criteria:
Exclusion Criteria:
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
Control group (patients without skin cancer) will have a skin imaging with a new Microscopy Optical Coherence (OCTAV)
Device: OCTAV 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.
Also known as: OCTAV, DAMAE Medical, Paris, France
In vivo skin imaging performed by placing the tip of the OCTAV device directly in slight contact with the skin of the patient.
Also known as: OCTAV, DAMAE Medical, Paris, France
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)
Time frame: 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)
Time frame: Day 1
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)
Time frame: Day 1
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Universitaire de Saint Etienne