Clinical trial · Observational
Vocal Folds Irregular Mucosal Changes: A Clinical, Pathological and Genetic Study
NCT04006197CI-TRIAL-00100210completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Vocal Cord Neoplasm | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| laryngostroboscopy and histoh-pathology | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Correlation between video-stroboscopic examination and histopathological results
- timeFrame
- baseline
- description
- Correlation between video-stroboscopic examination and histopathological groups.
Secondary outcomes (1)
- measure
- to correlate between SOX2 gene expression and histopathological finding
- timeFrame
- baseline
- description
- to correlate between SOX2 gene expression and histopathological finding and if can give the same diagnosis of histopathology or not
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (3)
- BACKGROUNDFerlito 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. PMID 21971762
- BACKGROUNDGugatschka 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. doi: 10.1007/s00405-007-0549-9. Epub 2007 Dec 4. PMID 18057948
- BACKGROUNDSadri M, McMahon J, Parker A. Management of laryngeal dysplasia: a review. Eur Arch Otorhinolaryngol. 2006 Sep;263(9):843-52. doi: 10.1007/s00405-006-0078-y. Epub 2006 Jul 6. PMID 16823559