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Optical Spectroscopy for Skin Carcinomas' Surgical Management (SPETROLIVE)

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ClinicalTrials.gov Identifier: NCT02956265
Recruitment Status : Recruiting
First Posted : November 6, 2016
Last Update Posted : January 3, 2020
Sponsor:
Collaborator:
University of Lorraine
Information provided by (Responsible Party):
Centre Hospitalier Régional Metz-Thionville

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Assessment of Optical Spectroscopy's (Combining Autofluorescence and Diffuse Reflectance) Diagnosis Accuracy (Sensitivity and Specificity) 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 : October 2016
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : March 31, 2021

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




Primary Outcome Measures :
  1. Optical spectroscopy's diagnostic validity for the 4 histological classes discrimination [ Time Frame: 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). [ 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02956265


Contacts
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Contact: Nadia OUAMARA +33 87 55 77 52 n.ouamara@chr-thionville.fr

Locations
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France
CHR Metz Thionville Recruiting
Metz, France, 57085
Contact: OUAMARA Nadia       n.ouamara@chr-metz-thionville.fr   
Sponsors and Collaborators
Centre Hospitalier Régional Metz-Thionville
University of Lorraine
Investigators
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Principal Investigator: Grégoire Khairallah g.khairallah@chr-metz-thionville.fr

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Responsible Party: Centre Hospitalier Régional Metz-Thionville
ClinicalTrials.gov Identifier: NCT02956265    
Other Study ID Numbers: 2016-05-CHRMT
First Posted: November 6, 2016    Key Record Dates
Last Update Posted: January 3, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms