SPECTROLIVE: Optical Spectroscopy for Skin Carcinomas' Surgical Management

• Sponsor: Centre Hospitalier Régional Metz-Thionville (Other)
• Overall Status: Completed
• CT.gov ID: NCT02956265
• Collaborator: University of Lorraine (Other)
• Enrollment: 142
• Location: 1
• Arm: 1
• Duration (Months): 53.7
• Patients Per Site Per Month: 2.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Carcinomatous or Polymorphous Skin Lesions	Device: bimodal optical spectroscopy	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 142 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• 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 Start Date: Oct 1, 2016
• Actual Primary Completion Date: Mar 25, 2021
• Actual Study Completion Date: Mar 25, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: 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:

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHR Metz Thionville	Metz		France	57085

Sponsors and Collaborators

• Centre Hospitalier Régional Metz-Thionville
• University of Lorraine

Investigators

• Principal Investigator: Grégoire Khairallah, [e-mail]

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Régional Metz-Thionville
• ClinicalTrials.gov Identifier: NCT02956265
• Other Study ID Numbers: 2016-05-CHRMT
• First Posted: Nov 6, 2016
• Last Update Posted: Mar 2, 2022
• Last Verified: Jun 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Carcinoma

Study Results

No Results Posted as of Mar 2, 2022