Clincosm LogoSign in Get a demo

FLUOROCORD: Characterization of the Autofluorescence of Healthy and Pathological Tissues of Vocal Cords

Sponsor
Centre Hospitalier Universitaire de Besancon (Other)
Overall Status
Completed
CT.gov ID
NCT03585075
Collaborator
(none)
30
Enrollment
1
Location
26
Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this clinical trial is to provide information about autofluorescence of pathological versus healthy vocal folds tissues.

Experimentations are performed on vocal folds biopsies obtained from patients, surgered at ENT department, university hospital of Besançon. After being extracted, samples of vocal folds are submitted to excitations at 365 nm, 405 nm and 450 nm; light spectral absorptions are measured, and results are compared to reference anatomopathology.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    30 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Caractérisation de l'Autofluorescence Des Tissus Sains et Pathologiques Des Cordes Vocales
    Study Start Date :
    Feb 1, 2014
    Actual Primary Completion Date :
    Feb 1, 2014
    Actual Study Completion Date :
    Apr 1, 2016

    Outcome Measures

    Primary Outcome Measures

    1. hyperspectral fluorescence of vocal folds [30 minutes after biopsy]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • patient view in ENT department, presenting vocal fold lesion that necessitate biopsy

    • patient informed and with non opposition

    Exclusion Criteria:

    • small (<1mm) and/or brittle sample

    • Patients in emergency situations, pregnant or nursing mothers, persons deprived of their liberty, minors or protected adults.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHRU de Besancon Besancon France 25000

    Sponsors and Collaborators

    • Centre Hospitalier Universitaire de Besancon

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Centre Hospitalier Universitaire de Besancon
    ClinicalTrials.gov Identifier:
    NCT03585075
    Other Study ID Numbers:
    • P/2014/216
    First Posted:
    Jul 12, 2018
    Last Update Posted:
    Jul 12, 2018
    Last Verified:
    Jun 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Laryngeal Neoplasms

    Study Results

    No Results Posted as of Jul 12, 2018