Optical Spectroscopy for Skin Carcinomas' Surgical Management (SPECTROLIVE)

February 14, 2022 updated by: Centre Hospitalier Régional Metz-Thionville

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

142

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Metz, France, 57085
        • CHR Metz Thionville

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients - Suffering from carcinomatous or polymorphous skin
Device: bimodal optical spectroscopy
an optical fiber will be put in gentle contact with the patient's skin in order to acquire optical spectra

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Optical spectroscopy's diagnostic validity for the 4 histological classes discrimination
Time Frame: day 1
day 1

Secondary Outcome Measures

Outcome Measure
Time Frame
Statistical significance degree of the discrimination by molecular profiling (transcriptomic characterization) between in situ carcinoma (ISC) and invasive carcinoma (InvC).
Time Frame: day 1
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
Time Frame: day 1
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.
Time Frame: day 1
day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Régional Metz-Thionville

Collaborators

University of Lorraine

Investigators

  • Principal Investigator: Grégoire Khairallah, g.khairallah@chr-metz-thionville.fr

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Actual)

March 25, 2021

Study Completion (Actual)

March 25, 2021

Study Registration Dates

First Submitted

November 3, 2016

First Submitted That Met QC Criteria

November 3, 2016

First Posted (Estimate)

November 6, 2016

Study Record Updates

Last Update Posted (Actual)

March 2, 2022

Last Update Submitted That Met QC Criteria

February 14, 2022

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-05-CHRMT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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