Vocal Cord Neoplasm Clinical Trial
Official title:
Vocal Folds Irregular Mucosal Changes: A Clinical, Pathological and Genetic Study
simple combination of functional investigation, in form of laryngostroboscopy, together with conventional histopathological examination, provides a highly sensitive method in differential diagnosis of undiagnosed vocal folds irregularites
Status | Not yet recruiting |
Enrollment | 100 |
Est. completion date | February 1, 2022 |
Est. primary completion date | February 1, 2022 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 70 Years |
Eligibility | inclusion criteria 1. Age 18-70 years old males 2. Unilateral or bilateral localized and diffuse vocal fold irregularities. 3. Patients with white (leukoplakia) patches on one or both vocal folds 4. No previous microphonosurgery. 5. No previous history of radiotherapy .6.No impairment of the vocal fold mobility. exclusion criteria 1. Subject refusal. 2. Patients with large exophytic and/or ulcerated mass. 3. Vocal fold cysts or polyps, contact granulomas, or Reinke's edema 4. If there is a concern for rapid growth pattern, airway obstruction requiring urgent operative intervention 5. Vocal fold immobility 6. History of allergies and GERD. 7. Unfit for general anesthesia |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Assiut University |
Ferlito A, Devaney KO, Woolgar JA, Slootweg PJ, Paleri V, Takes RP, Strojan P, Bradley PJ, Rinaldo A. Squamous epithelial changes of the larynx: diagnosis and therapy. Head Neck. 2012 Dec;34(12):1810-6. doi: 10.1002/hed.21862. Epub 2011 Oct 3. Review. — View Citation
Gugatschka M, Kiesler K, Beham A, Rechenmacher J, Friedrich G. Hyperplastic epithelial lesions of the vocal folds: combined use of exfoliative cytology and laryngostroboscopy in differential diagnosis. Eur Arch Otorhinolaryngol. 2008 Jul;265(7):797-801. Epub 2007 Dec 4. — View Citation
Sadri M, McMahon J, Parker A. Management of laryngeal dysplasia: a review. Eur Arch Otorhinolaryngol. 2006 Sep;263(9):843-52. Epub 2006 Jul 6. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
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Primary | measurment of incidance of vocal folds dysplasia from all cases of vocal folds irregular mucosal changes in phoniatric unit of assiut university hospital within the two years of study | detect how many cases with vocal folds dysplasia througth comination of laryngostoboscopy and histopathology for acases of undiagnosed vocal folds irregular mucosal changes. | baseline | |
Secondary | to correlate between laryngostroboscopic and histopathological finding | detect to what extent using of laryngostroboscopy can give the same diagnosis of histopathology or not | baseline |
Status | Clinical Trial | Phase | |
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Enrolling by invitation |
NCT05323292 -
Vitamin A Status in Patients With Vocal Fold Leukoplakia
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