Clinical trial · Interventional
Optical Spectroscopy for Skin Carcinomas' Surgical Management
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinomatous or Polymorphous Skin Lesions | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bimodal optical spectroscopy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patients - Suffering from carcinomatous or polymorphous skin
- interventionNames
- Device: bimodal optical spectroscopy
Primary outcomes (1)
- measure
- Optical spectroscopy's diagnostic validity for the 4 histological classes discrimination
- timeFrame
- day 1
Secondary outcomes (3)
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (3)
- RESULTZghal 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.
- RESULTBlondel 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.
- RESULTElsen 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