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RecruitingNCT06779799BAMBOOUpdated Jan 17, 2025

Characterization of "Bamboo" and Other Vocal Cord Lesions Responsible for Dysphonia in Patients With Systemic Autoimmune Diseases (BAMBOO)

An observational study in Dysphonia, Connective Tissue Disease and Vasculitis, sponsored by University Hospital, Brest. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-17.

Sponsored by University Hospital, Brest · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
150
Ages
18 Years and older
Sex
All
01

Study summary

The goal of this multicenter retrospective observational study is to provide an inventory of the specific and non specific cord vocal lesions that can cause dysphonia in patients with systemic autoimmune diseases. The main question it aims to answer is:

  • What are the main cord vocal lesions responsible for dysphonia in patients with a systemic autoimmune disease?
  • Is there a diagnosis delay regarding those lesions?
  • How are those lesions managed? Participants suffering from dysphonia in a context of a systemic autoimmune disease will be identified, with a review of their medical record.
Read the detailed description

Patients with a systemic autoimmune disease may face to the occurrence of a dysphonia during the course of their disease. Specific etiologies must be sought for, such as "bamboo nodes", previously reported on small series, especially in patients with systemic erythematosus lupus, but also in other connective tissue disease such as Sharp syndrome, primary Sjögren disease and anti-synthetase syndrome. These nodes are made of fibrosis and immune complexes have been described. The treatment relies on vocal reeducation, oral steroids and sometimes surgery. Other irritative factors must be avoided such as stopping tobacco or treating a gastroesophageal reflux. Increasing the immunosuppressive regimen of the autoimmune disease has also been suggested, but the management is not codified due to the rarity of this condition. Rheumatoid nodules of the vocal cords have also been described in rheumatoid arthritis as well as cricoarytenoid joint arthritis. Granuloma of the vocal cords have also been reported in granulomatosis with polyangiitis. Other non specific etiologies should also be sought for such as mucosal ulcerations, submucous edema or hematoma, or vocal cord palsy.

Owing to the rare series of dysphonia reported in a context of systemic auto-immunity, the aim of this retrospective study is to provide an inventory of the specific and non specific lesions that can cause dysphonia in patients with systemic autoimmune diseases, with the assessment of potential diagnosis delays and therapeutics.

Main objective : To characterize the cord vocal lesions responsible for dysphonia in patients with systemic autoimmune diseases.

Secondary objectives :

  • To assess the proportion of "bamboo nodes" compared to non specific lesions in patients with a systemic autoimmune disease suffering from dysphonia.
  • To identify potential diagnosis delays.
  • To describe the management of these lesions.
  • To identify risk factors associated with these lesions.
02

Conditions studied

03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Patients aged 18 years or older suffering from dysphonia in a context of a systemic autoimmune disease.

Inclusion criteria

  • Patients aged 18 years or older
  • With a systemic autoimmune disease : rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis, primary Sjogren disease, sarcoidosis, vasculitis, myositis, Still disease, Sharp syndrome.
  • Suffering from dysphonia.
  • With a cord vocal/laryngeal lesion highlighted.

Exclusion criteria

Exclusion Criteria:

  • Patients under the age of 18 years
  • Dysphonia due to a cord vocal palsy related to a neurological condition or malignancy
  • History of cervical radiation
  • History of oro-tracheal intubation
  • Laryngeal cancer
  • Participation deny
  • Impossibility of consent
  • Patients with legal protection
04

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
150 participants (estimated)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. Nature of the cord vocal lesion responsible for dysphonia according to the physician (otorhinolaryngologist, rheumatologist or internist) from medical record

    Diagnosis of the lesion responsible for dysphonia will be determined from medical record : medical report of the otorhinolaryngologist and/or laryngoscopy report if available or anatomopathological report in case of biopsy/surgery of the lesion. If no report from the otorhinolaryngologist is found in the record, then the reported diagnosis from the rheumatologist or the internist will be considered.

    Time frame: between january 2014 and december 2024

06

Study locations

1 of 1 sites recruiting
  • Chu Brest
    Brest, 29609, France
    Recruiting
07

References and documents

Individual participant data

Plan to share: Yes — All collected data that underlie results in a publication

Supporting information: Study protocol

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06779799
Lead sponsor
University Hospital, Brest
Responsible party
Sponsor
First posted
Jan 17, 2025
Start date
Dec 1, 2024
Primary completion
May 31, 2025 (estimated)
Completion
May 31, 2025 (estimated)
Last update
Jan 17, 2025

Study contacts

Alice TISON
Contact
alice.tison@chu-brest.fr
0298347264 ext. +33
Clément SARRAUSTE
Contact
clement.sarrauste@chu-brest.fr
0298347264 ext. +33

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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