About this trial
The background to this research is that frequent medical screening of the general population for melanoma is not feasible. The real challenge of this project is to develop an automatic process for detecting any potential melanoma. To this end, the project aims to design an algorithm to build a novel diagnostic aid that makes use of the similarity and disparity of pigmented lesions in the same patient. To achieve this, we need to obtain and structure a large database of images grouping all pigmented lesions per patient according to their similarities as perceived by dermatologists.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Male or female aged 18 and over
Patient with more than 15 nevi (moles) of various phototypes (I to III)
Patient who has received information about the study and has not expressed any opposition
Patient who is a beneficiary or entitled person under a social security scheme
Disqualifiers
Patients with phototype V
Patients with chronic inflammatory skin diseases
Claustrophobic patients
Patients who are bedridden or handicapped
Trial design
Single group
Treatments tested in this trial
Scanner of the whole body using the VECTRA 3D
Other interventionWhole body image acquisition using the VECTRA 3D Whole Body 360 Imaging System to detect potential melanoma
Treatment groups
Trial outcomes
Primary outcomes
development and validation of algorithms to identify lesions clinically suspected of being melanoma by a dermatologist (potentially malignant and/or ugly duckling).
Comparison of the results given by the analysis of the images by 3 dermatologists or by the software. Estimation of sensitivity and specificity thresholds of at least 93% (accuracy level 5%).
Secondary outcomes
concordance rate for malignant annotations
concordance between the malignant yes-no annotations of each of the three dermatologists (2 to 2) will be tested.
concordance rate for ugly duckling
concordance between the ugly duckling yes-no annotations of each of the three dermatologists (2 to 2) will be tested.
calculation of the proportion of melanomas confirmed by anatomopathology
For each lesion identified as malignant or ugly duckling by the gold standard and removed for histological analysis: calculation of the proportion of melanomas confirmed by pathology.
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: