Laryngeal NeoplasmsFLUOROCORDNCT03585075
Characterization of the Autofluorescence of Healthy and Pathological Tissues of Vocal Cords
An observational study of Laryngeal Neoplasms, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Laryngeal Neoplasms
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2014to Apr 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Samples of vocal folds from ENT surgery department, University Hospital of Besançon
Who may be able to join
- patient view in ENT department, presenting vocal fold lesion that necessitate biopsy
- patient informed and with non opposition
Who cannot join
- small (<1mm) and/or brittle sample
- Patients in emergency situations, pregnant or nursing mothers, persons deprived of their liberty, minors or protected adults.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Caractérisation de l'Autofluorescence Des Tissus Sains et Pathologiques Des Cordes Vocales
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.
- Conditions
- Laryngeal Neoplasms
- Medical subject headings
- Laryngeal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
hyperspectral fluorescence of vocal folds
Measured: 30 minutes after biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2018
- Study startFeb 2014
- Primary completionFeb 2014
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laryngeal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03585075
- Sponsor's protocol ID
- P/2014/216
- Acronym
- FLUOROCORD
- Status last verified
- Jun 2018
- First submitted
- 29 Jun 2018
- Last updated
- 12 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caractérisation de l'Autofluorescence Des Tissus Sains et Pathologiques Des Cordes Vocales
- ClinicalTrials.gov ID
- NCT03585075
- Acronym / sponsor ID
- FLUOROCORD / P/2014/216
- Conditions
- Laryngeal Neoplasms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Feb 2014 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 12 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Samples of vocal folds from ENT surgery department, University Hospital of Besançon
Key inclusion criteria (2 listed)
- patient view in ENT department, presenting vocal fold lesion that necessitate biopsy
- patient informed and with non opposition
Key exclusion criteria (2 listed)
- small (<1mm) and/or brittle sample
- Patients in emergency situations, pregnant or nursing mothers, persons deprived of their liberty, minors or protected adults.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
hyperspectral fluorescence of vocal folds
Time frame: 30 minutes after biopsy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Laryngeal Neoplasms, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hyperspectral fluorescence of vocal folds (time frame: 30 minutes after biopsy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2018.