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
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:
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 :
132 studies on the registry are indexed under Dysphonia; 38 are open to participants now.
This study's planned enrollment of 150 is above the median of 123 across 40 observational studies indexed under Dysphonia.
Browse Dysphonia studies →University Hospital, Brest is the lead sponsor of 601 studies on the registry; 136 are open to participants now.
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Patients aged 18 years or older suffering from dysphonia in a context of a systemic autoimmune disease.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Plan to share: Yes — All collected data that underlie results in a publication
Supporting information: 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
No publications or documents are linked to this record.
Started Dec 2024 (actual). Primary completion is estimated for May 2025, 5 months after the start.
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