Optical Spectroscopy for Skin Carcinomas' Surgical Management

NCT02956265 | Completed DMC

• 1 other identifier: 2016-05-CHRMT
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Optical spectroscopy's diagnostic validity for the 4 histological classes discrimination

  day 1

Secondary Outcomes (3)

• 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

Study Arms (1)

Patients - Suffering from carcinomatous or polymorphous skin

EXPERIMENTAL

Device: bimodal optical spectroscopy

Interventions

bimodal optical spectroscopy DEVICE

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

Patients - Suffering from carcinomatous or polymorphous skin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Régional Metz-Thionville: lead
• University of Lorraine: collaborator

Study Sites (1)

CHR Metz Thionville

Metz, 57085, France

Location

Related Publications (3)

• Zghal A., Fauvel C., Kupriyanov V., Elsen T., Khairallah G., Blondel W., Amouroux M. Adv. Biomed. Clin. Diagn. Surg. Guid. Syst. XXI. SPIE; 2023. Human skin phototype and apparent age classification based on machine learning methods of autofluorescence and diffuse reflectance spectroscopic data acquired in vivo; pp. 60-64.

  RESULT

• Blondel W., Delconte A., Khairallah G., Marchal F., Gavoille A., Amouroux M. Spatially-resolved multiply-excited autofluorescence and diffuse reflectance spectroscopy: spectrolive medical device for skin in vivo optical biopsy. Electronics. 2021;10:243. doi: 10.3390/electronics10030243.

  RESULT

• Elsen T, Fauvel C, Khairallah G, Zghal A, Delconte A, Kupriyanov V, Blondel W, Amouroux M. A dataset of optical spectra and clinical features acquired on human healthy skin and on skin carcinomas. Data Brief. 2024 Feb 6;53:110163. doi: 10.1016/j.dib.2024.110163. eCollection 2024 Apr.

  PMID: 38375145 RESULT

Study Officials

• Grégoire Khairallah

  g.khairallah@chr-metz-thionville.fr

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2016
• First Posted: November 7, 2016
• Study Start: October 1, 2016
• Primary Completion: March 25, 2021
• Study Completion: March 25, 2021
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)