Skip to main content
OpenTrials
Completed

NCT Number: NCT02956265

Optical Spectroscopy for Skin Carcinomas' Surgical Management

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHR Metz Thionville

Metz, 57085, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

bimodal optical spectroscopy

Device

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

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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Régional Metz-Thionville

Other

Collaborators

  • University of Lorraine

Registry information

Official study title

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.

Acronym: SPECTROLIVE

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Nov 7, 2016
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.