Skin Lesion
Conditions
Brief summary
Skin cancers represent a real public health issue. The diagnosis of pre-cancerous lesions thus is a priority. The diagnosis gold standard is based on the combination of clinical and histopathological examinations. Nevertheless, the clinical examination is not sufficiently effective, meaning that a biopsy has to be done for each suspected lesion. In order to avoid unnecessary biopsy excisions, a new medical device (DERMAPOL) was designed to help dermatologists in diagnosing skin lesions. This medical device combined with its software is a strong and ergonomic spectro-polarimetric imager instrument. It can realize images of the superficial cutaneous tissues and subcutaneous tissues close to the surface by exploiting polarized light properties. This first clinical trial aims to demonstrate that this medical device is able to segment effectively healthy and tumor tissues and that it can correlate main semiological elements (identified thanks to the clinical and histopathological examinations) to the physico-optical characteristics obtained on the images of the medical device.
Interventions
DEVICEDermapol
Use of the experimental medical device before lesion excision : skin lesion lighting (4 wavelengths) for less than 1 minute and image recording
Sponsors
University Hospital, Strasbourg, France
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* adult patient with a skin tumor (benign or cancerous) which has to be excised and analysed according to histopathological examination * skin lesion belonging to one of these groups (diagnosed by clinical examination): * cutaneous cyst * seborrhoeic keratosis * cutaneous carcinoma * naevus * melanoma * actinic keratosis and cutaneous horn * other skin tumors * skin lesion size equal to or less than 5 cm * signed written consent form * patient affiliated to a social insurance
Exclusion criteria
* skin lesion size strictly over than 5 cm * eyelid lesion * aluminium, POM (polyoxymethylene) or organic glass allergy * known pregnancy, breast-feeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of lesions with semiological characteristics | Before biopsy | Proportion of lesions for which at least one semiological characteristic (detected by the combination of visual and histopathological examinations) was identified by the medical device thanks to physico-optical properties |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Specificity, sensitivity and predictive values | Before biopsy | Specificity, sensitivity, true positive rate, true negative rate, false positive rate, false negative rate of the medical device, for each semiological characteristic identified by the combination of the clinical and histopathological examinations |
| Physico-optical description of the lesions | Before biopsy | Physico-optical description of the cutaneous lesions by the medical device |
| Number of different semiological characteristics | Before biopsy | Number of different semiological characteristics visualized by the medical device and by the combination of clinical and histopathological examinations for each image processing |
| Proportion of semiological characteristics properly identified | Before biopsy | Proportion of semiological characteristics properly identified by the medical device for all lesions |
| Cases proportion for which the same semiological characteristics list was found between the medical device and the combination of clinical and histopathological diagnosis | Before biopsy | Proportion of cases with same semiological characteristics list |
Countries
France
Outcome results
None listed