Optical Spectroscopy for Skin Carcinomas' Surgical Management (SPECTROLIVE)
Primary Purpose
Carcinomatous or Polymorphous Skin Lesions
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
bimodal optical spectroscopy
Sponsored by

About this trial
This is an interventional diagnostic trial for Carcinomatous or Polymorphous Skin Lesions
Eligibility Criteria
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.
Sites / Locations
- CHR Metz Thionville
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients - Suffering from carcinomatous or polymorphous skin
Arm Description
Outcomes
Primary Outcome Measures
Optical spectroscopy's diagnostic validity for the 4 histological classes discrimination
Secondary Outcome Measures
Statistical significance degree of the discrimination by molecular profiling (transcriptomic characterization) between in situ carcinoma (ISC) and invasive carcinoma (InvC).
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
- 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.
Full Information
NCT ID
NCT02956265
First Posted
November 3, 2016
Last Updated
February 14, 2022
Sponsor
Centre Hospitalier Régional Metz-Thionville
Collaborators
University of Lorraine
1. Study Identification
Unique Protocol Identification Number
NCT02956265
Brief Title
Optical Spectroscopy for Skin Carcinomas' Surgical Management
Acronym
SPECTROLIVE
Official 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.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
October 2016 (undefined)
Primary Completion Date
March 25, 2021 (Actual)
Study Completion Date
March 25, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Régional Metz-Thionville
Collaborators
University of Lorraine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinomatous or Polymorphous Skin Lesions
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
142 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients - Suffering from carcinomatous or polymorphous skin
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
bimodal optical spectroscopy
Intervention Description
an optical fiber will be put in gentle contact with the patient's skin in order to acquire optical spectra
Primary Outcome Measure Information:
Title
Optical spectroscopy's diagnostic validity for the 4 histological classes discrimination
Time Frame
day 1
Secondary Outcome Measure Information:
Title
Statistical significance degree of the discrimination by molecular profiling (transcriptomic characterization) between in situ carcinoma (ISC) and invasive carcinoma (InvC).
Time Frame
day 1
Title
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
Title
- 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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Grégoire Khairallah
Organizational Affiliation
g.khairallah@chr-metz-thionville.fr
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHR Metz Thionville
City
Metz
ZIP/Postal Code
57085
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
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Optical Spectroscopy for Skin Carcinomas' Surgical Management
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