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Biopsy-confirmed diagnosis of hyperkeratosis with dysplasia.

Biopsy-confirmed diagnosis of hyperkeratosis with no dysplasia.

Laryngoscopy showing no evidence of vocal fold mucosal disease.

Nathan Welham, PhD, CCC-SLP

This study will determine systemic vitamin A status and lesion histopathology of participants with vocal fold hyperkeratosis resulting in clinical leukoplakia.

The investigator's overarching goal is to determine if there is a pathophysiologic rationale for vitamin A supplementation in the treatment of vocal fold hyperkeratosis. Vocal fold hyperkeratosis is an accumulation of epithelial surface keratin resulting in clinical leukoplakia. It is primarily managed using destructive techniques that risk iatrogenic injury, fibrosis, and voice impairment. Given the potential morbidity of biopsy and lesion removal, there is a need for new approaches to the prevention and treatment of vocal fold leukoplakic disorders that are non-destructive. Vitamin A is a key regulator of epithelial health and systemic vitamin A deficiency could directly contribute to hyperkeratosis. Based on vitamin A's importance to vocal fold stellate and epithelial cell biology and its direct relevance to vocal fold hyperkeratosis, this study will assess vitamin A status in participants with vocal fold hyperkeratosis. An association would suggest further study on the effects of vitamin A optimization and/or supplementation in patients with leukoplakia, as well as an adjuvant therapy in participants for whom surgical treatment is indicated.

Vitamin A Status in Patients With Vocal Fold Leukoplakia

Total vitamin A liver concentration determined using retinol stable isotope dilution (μmol/g)

Serum retinyl esters concentration (μmol/L)

Serum carotenoid concentrations (μmol/L)

National Institute on Deafness and Other Communication Disorders (NIDCD)

University of Wisconsin, Madison

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.

laryngostroboscopy and histoh-pathology

Amira Abdelaal, MD

Essam Aref, MD

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

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

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

detect how many cases with vocal folds dysplasia througth comination of laryngostoboscopy and histopathology for acases of undiagnosed vocal folds irregular mucosal changes.

detect to what extent using of laryngostroboscopy can give the same diagnosis of histopathology or not

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Vitamin A Status in Patients With Vocal Fold Leukoplakia	NCT05323292	Vitamin A Vitamin A Defic... Leukoplakia Vocal Cord Neop...		18 Years -	University of Wisconsin, Madison
Vocal Folds Irregular Mucosal Changes: A Clinical, Pathological and Genetic Study	NCT04006197	Vocal Cord Neop...	laryngostrobosc...	18 Years - 70 Years	Assiut University
Vitamin A Status in Patients With Vocal Fold Leukoplakia	NCT05323292	Vitamin A Vitamin A Defic... Leukoplakia Vocal Cord Neop...		18 Years -	University of Wisconsin, Madison

Spots Global Cancer Trial Database for vocal cord neoplasm