Vocal Folds Irregular Mucosal Changes: A Clinical, Pathological and Genetic Study

Vocal Cord Neoplasm Clinical Trial

Official title:

Vocal Folds Irregular Mucosal Changes: A Clinical, Pathological and Genetic Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04006197
• Other study ID #: Vocal folds irregular mucosa
• Status: Not yet recruiting
• Start date: February 1, 2021
• Est. completion date: February 1, 2022

Study information

• Verified date: January 2021
• Source: Assiut University
• Contact: Amira Abdelaal, MD
• Phone: 01009699346
• Email: amirahafez204[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

Vocal folds irregular mucosal changes often manifest as mucosal surface changes of leukoplakia, erythroplakia and keratosis associated with tissue irregularities. Lesions that go beyond the outermost layer of the vocal fold and invade the intermediate and deep layers. These gross mucosal changes may represent benign, premalignant, or malignant entities as they correspond to large spectrum of lesions ranging from simple totally benign keratosis with or without atypia up to invasive carcinoma, it is commonly encountered in phoniatrics clinic and presents diagnostic and therapeutic challenge as there is no unified surgical indication or guidelines. Laryngostroboscopy is very important and primary tool for assessment of morphological features and vibratory functions of the vocal folds. Stroboscopic evaluation allows early detection of infiltrative processes of the vocal folds. However, the laryngoscope examination may not always be sufficient to assess premalignant lesions and their exact delineation. Gugatschka et al., 2008 reported that videostroboscopic evaluation allows early detection of infiltrative processes of the vocal folds, as they achieved a sensitivity of more than 97 %, when used a combination of cytology and videostroboscopy, in contrast to 74 % as found by cytology alone. Zhang et al., 2018 proposed to classify VF leukoplakia into three types according to the morphological appearance. The evaluated features included texture, color, and thickness. They proved that type III-bulge and rough-with irregular, nonhomogeneous leukoplakia higher than mucosa surface was more often associated with cancerization or severe dysplasia in 29.3% and 21.5% cases, respectively, comparing to the respective percentages of 4.0% and 3.7% for type I-flat and smooth leukoplakia. Anna Rzepakowska et al submitted a protocol for evaluation of the morphological characteristics of leukoplakia which involved the following features of the lesion: color, texture, size, thickness, symmetry and vibratory function. Each character was assigned with the score of zero or one (score zero was considered to be a clinical indicator of benign lesions, while, score one was a clinical indicator of malignancy). Recent advances in basic research have improved understanding of underlying mechanisms of molecular processes in early stages of laryngeal cancer development. The SOX2 gene located at 3q26 is frequently amplified and overexpressed in multiple cancers, including head and neck squamous cell carcinomas (HNSCC). The tumor-promoting activity and involvement of SOX2 in tumor progression has been extensively demonstrated, thereby emerging as a promising therapeutic target. However, the role of SOX2 in early stages of tumorigenesis and its possible contribution to malignant transformation remain unexplored. Granda-Diaz etal., 2019 investigated for the first time SOX2 gene in precancerous lesion using real-time PCR and demonstrated that SOX2 protein expression and gene amplification are frequent events in early stages of laryngeal tumorigenesis

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Vocal Cord Neoplasm

Intervention

Other:
• laryngostroboscopy and histoh-pathology
videolaryngoscopy and laryngostroboscoby will be performed .the latter will be pathological in case of highly reduced or abolished amplitudes of vocal fold vibration and if there is reduction of mucosal wave propagation.also direct microlaryngoscopy under general anathesia will be done and excesional biobsy will be taken followed by histopatholpgical examination .the histological finding will be catagorized into the following categories according to (WHO): squamous cell hyperplasia with non dysplasia,mild dysplasia,moderate dysplasia,sever dysplasia,carcinoma in situ and squamous cell carcinoma.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (3)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
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