Optical Spectroscopy for Skin Carcinomas' Surgical Management (SPECTROLIVE)

Centre Hospitalier Régional Metz-Thionville

Status

Completed

Conditions

Carcinomatous or Polymorphous Skin Lesions

Treatments

Device: bimodal optical spectroscopy

Study type

Interventional

Funder types

Other

Identifiers

NCT02956265

2016-05-CHRMT

Details and patient eligibility

About

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.

Enrollment

142 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Adults, and
Autonomous: enjoying full citizenship rights and full mental abilities, and
Affiliated to a social security system, and
Suffering from carcinomatous or polymorphous skin lesions that can be fully managed in an outpatient (ambulatory) surgery procedure.

Exclusion criteria

Carcinomatous or polymorphous skin lesions that require day admission, or
Carcinomatous or polymorphous skin lesions for which resection margins are uncertain, or
Naevomatous skin lesions and related skin pathologies.