Working... Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03585075
Recruitment Status : Completed
First Posted : July 12, 2018
Last Update Posted : July 12, 2018
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

Layout table for study information
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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
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

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 identifier (NCT number): NCT03585075

Layout table for location information
CHRU de Besancon
Besancon, France, 25000
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon

Layout table for additonal information
Responsible Party: Centre Hospitalier Universitaire de Besancon 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:
Layout table for MeSH terms
Laryngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Laryngeal Diseases
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Otorhinolaryngologic Diseases