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CompletedNCT02956265SPECTROLIVEUpdated Apr 24, 2026

Optical Spectroscopy for Skin Carcinomas' Surgical Management

An interventional study of bimodal optical spectroscopy in Carcinomatous or Polymorphous Skin Lesions, sponsored by Centre Hospitalier Régional Metz-Thionville. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-24.

Sponsored by Centre Hospitalier Régional Metz-Thionville · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
142
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.
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Conditions studied

  • Carcinomatous or Polymorphous Skin Lesions
03

In context

Lead sponsor

Centre Hospitalier Régional Metz-Thionville is the lead sponsor of 118 studies on the registry; 20 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
142 participants (actual)

Study arms

  • Experimental
    Patients - Suffering from carcinomatous or polymorphous skin

    Device: bimodal optical spectroscopy

Interventions

  • Devicebimodal optical spectroscopy

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

06

What researchers measure

Primary outcomes

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

    Time frame: day 1

Secondary outcomes

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

    Time frame: day 1

  2. 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

    Time frame: day 1

  3. - 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.

    Time frame: day 1

07

Study locations

1 site
  • CHR Metz Thionville
    Metz, 57085, France
08

References and documents

Publications

  • 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.
  • 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.
  • 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. PubMed 38375145 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02956265
Lead sponsor
Centre Hospitalier Régional Metz-Thionville
Collaborators
University of Lorraine
Responsible party
Sponsor
First posted
Nov 7, 2016
Start date
Oct 2016
Primary completion
Mar 25, 2021
Completion
Mar 25, 2021
Last update
Apr 24, 2026

Study contacts

Grégoire Khairallah
principal investigator · g.khairallah@chr-metz-thionville.fr

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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