Optical Spectroscopy for Skin Carcinomas' Surgical Management

NCT ID: NCT02956265

Last Updated: 2022-03-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 142 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2021-03-25

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.

Conditions

Carcinomatous or Polymorphous Skin Lesions

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Patients - Suffering from carcinomatous or polymorphous skin

Group Type: EXPERIMENTAL

bimodal optical spectroscopy

Intervention Type: DEVICE

an optical fiber will be put in gentle contact with the patient's skin in order to acquire optical spectra

Interventions

bimodal optical spectroscopy

an optical fiber will be put in gentle contact with the patient's skin in order to acquire optical spectra

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Lorraine

OTHER

Sponsor Role: collaborator

Centre Hospitalier Régional Metz-Thionville

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Grégoire Khairallah

Role: PRINCIPAL_INVESTIGATOR

g.khairallah@chr-metz-thionville.fr

Locations

CHR Metz Thionville

Metz, , France

Countries

France

Other Identifiers

2016-05-CHRMT

Identifier Type: -

Identifier Source: org_study_id