Optical Spectroscopy for Skin Carcinomas' Surgical Management

Not Applicable

Completed

• Conditions: Carcinomatous or Polymorphous Skin Lesions
• Interventions: Device: bimodal optical spectroscopy

• Registration Number: NCT02956265
• Lead Sponsor: Centre Hospitalier Régional Metz-Thionville

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10
• Study First Submitted: 2016-11-03
• Study First Submitted QC: 2016-11-03
• Study First Posted: 2016-11-06
• Primary Completion: 2021-03-25
• Study Completion: 2021-03-25
• Status Verified: 2021-06
• Last Update Submitted: 2022-02-14
• Last Update Posted: 2022-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 142

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients - Suffering from carcinomatous or polymorphous skin	bimodal optical spectroscopy	-

Primary Outcome Measures

Name	Time	Method
Optical spectroscopy's diagnostic validity for the 4 histological classes discrimination	day 1

Secondary Outcome Measures

Name	Time	Method
Statistical significance degree of the discrimination by molecular profiling (transcriptomic characterization) between in situ carcinoma (ISC) and invasive carcinoma (InvC).	day 1
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	day 1
- 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.	day 1

Trial Locations

Locations (1)

CHR Metz Thionville; 🇫🇷 Metz, France