跳至主要内容
临床试验/NCT06779799
NCT06779799招募中不适用

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

University Hospital, Brest1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2024年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
150
试验地点
1
主要终点
Nature of the cord vocal lesion responsible for dysphonia according to the physician (otorhinolaryngologist, rheumatologist or internist) from medical record

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

结局指标

主要结局

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

时间窗: between january 2014 and december 2024

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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验