Clinical trial NCT02956265: Optical Spectroscopy for Skin Carcinomas' Surgical Management
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carcinomatous or Polymorphous Skin Lesions
Lead sponsor: Centre Hospitalier Régional Metz-Thionville
Sponsor class: OTHER
Collaborators: name: University of Lorraine
First posted: 2016-11-06
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Optical spectroscopy's diagnostic validity for the 4 histological classes discrimination
timeFrame: day 1
Secondary outcomes:
measure: Statistical significance degree of the discrimination by molecular profiling (transcriptomic characterization) between in situ carcinoma (ISC) and invasive carcinoma (InvC).
timeFrame: day 1
measure: Statistical significance degree of the discrimination by molecular profiling (transcriptomic characterization) between 2 classes of actinic keratosis (AK) of clinical relevance: AK characterized by a "low" versus a "high" invasiveness risk
timeFrame: day 1
measure: - Sensitivity and specificity of optical spectroscopy for discriminating the é molecular classes of actinic keratosis: AK characterized by a "low" versus a "high" invasiveness risk.
timeFrame: day 1
Other outcomes:
Locations:
city: Metz
country: France
facility: CHR Metz Thionville
Study officials:
affiliation: g.khairallah@chr-metz-thionville.fr
name: Grégoire Khairallah
role: PRINCIPAL_INVESTIGATOR
References: