NCT02956265

Optical Spectroscopy for Skin Carcinomas' Surgical Management

Assessment of Optical Spectroscopy's Diagnosis Accuracy When Non-invasively and Automatically Classifying Skin Lesions in One of the Following Histological Classes: Healthy, Actinic Keratosis, in Situ Carcinoma and Invasive Carcinoma.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 142 (actual)
• Sponsor: Centre Hospitalier Régional Metz-Thionville · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Actinic keratosis are of utmost medical and economical interest because of their high prevalence (20 % of 60 year-old people and older in the Northern hemisphere) and their important cosmetic impact as such actinic keratosis mostly appear on photo-exposed skin sites. The surgeon in charge of such lesions' removal (i) some actinic keratosis adjoining carcinoma to be resected therefore causing the problem of functional areas damaging (eyelids, lips, etc.) or (ii) numerous actinic keratosis localized away from carcinoma (photo-carcinogenesis field) faces the issue of clinical evaluation of such lesions: which ones will spontaneously regress (it is supposed to be the case for 20 % of such lesions);which ones will remain and which ones will develop into invasive carcinomas ? A non-invasive, non-traumatic, automated and real-time help for the clinical diagnosis orientation of such skin lesions could help improving diagnosis accuracy of the medical practitioner's visual inspection: * In terms of sensitivity in order to potentially decrease the number of actinic keratosis evolving towards invasive carcinoma, * In terms of specificity in order to potentially decrease useless resections and reduce resection margins and therefore reduce scars surface.

Conditions

• Carcinomatous or Polymorphous Skin Lesions

Interventions

Type	Name	Description
DEVICE	bimodal optical spectroscopy	an optical fiber will be put in gentle contact with the patient's skin in order to acquire optical spectra

Timeline

• Start date: 2016-10-01
• Primary completion: 2021-03-25
• Completion: 2021-03-25
• First posted: 2016-11-07
• Last updated: 2022-03-02

Locations

1 site across 1 country: France