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Characterization of the Autofluorescence of Healthy and Pathological Tissues of Vocal Cords (FLUOROCORD)

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ClinicalTrials.gov Identifier: NCT03585075
Recruitment Status : Completed
First Posted : July 12, 2018
Last Update Posted : July 12, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon

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
Laryngeal Neoplasms

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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 : February 2014
Actual Primary Completion Date : February 2014
Actual Study Completion Date : April 2016



Primary Outcome Measures :
  1. hyperspectral fluorescence of vocal folds [ Time Frame: 30 minutes after biopsy ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Samples of vocal folds from ENT surgery department, University Hospital of Besançon
Criteria

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.

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): NCT03585075


Locations
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France
CHRU de Besancon
Besancon, France, 25000
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon

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Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT03585075     History of Changes
Other Study ID Numbers: P/2014/216
First Posted: July 12, 2018    Key Record Dates
Last Update Posted: July 12, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Laryngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Laryngeal Diseases
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Otorhinolaryngologic Diseases