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

NCT06779799 | Recruiting

• 1 other identifier: 29BRC24.0332 - BAMBOO
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dysphonia; Connective Tissue Disease; Vasculitis

Outcome Measures

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.

  between january 2014 and december 2024

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

Chu Brest

Brest, 29609, France

RECRUITING

MeSH Terms

Conditions

Dysphonia; Connective Tissue Diseases; Vasculitis

Condition Hierarchy (Ancestors)

Voice Disorders; Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Alice TISON

CONTACT

0298347264; alice.tison@chu-brest.fr

Clément SARRAUSTE

CONTACT

0298347264; clement.sarrauste@chu-brest.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2025
• First Posted: January 17, 2025
• Study Start: December 1, 2024
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: January 17, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available beginning three years and ending fifteen years following the final study report completion
• Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement

Locations

FR (1)