NCT03585075

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

June 29, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 12, 2018

Completed
Last Updated

July 12, 2018

Status Verified

June 1, 2018

Enrollment Period

Same day

First QC Date

June 29, 2018

Last Update Submit

June 29, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • hyperspectral fluorescence of vocal folds

    30 minutes after biopsy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Samples of vocal folds from ENT surgery department, University Hospital of Besançon

You may qualify if:

  • patient view in ENT department, presenting vocal fold lesion that necessitate biopsy
  • patient informed and with non opposition

You may not qualify if:

  • small (\<1mm) and/or brittle sample
  • Patients in emergency situations, pregnant or nursing mothers, persons deprived of their liberty, minors or protected adults.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU de Besancon

Besançon, 25000, France

Location

MeSH Terms

Conditions

Laryngeal Neoplasms

Condition Hierarchy (Ancestors)

Otorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNeoplasmsLaryngeal DiseasesRespiratory Tract DiseasesRespiratory Tract NeoplasmsOtorhinolaryngologic Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2018

First Posted

July 12, 2018

Study Start

February 1, 2014

Primary Completion

February 1, 2014

Study Completion

April 1, 2016

Last Updated

July 12, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations