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Vocal Folds Irregular Mucosal Changes: A Clinical, Pathological and Genetic Study
| Condition or disease | Intervention/treatment |
|---|---|
| Vocal Cord Neoplasm | Other: laryngostroboscopy and histoh-pathology |
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
| Study Type : | Observational |
| Estimated Enrollment : | 100 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Vocal Folds Irregular Mucosal Changes: A Clinical, Pathological and Genetic Study |
| Estimated Study Start Date : | February 1, 2021 |
| Estimated Primary Completion Date : | February 1, 2022 |
| Estimated Study Completion Date : | February 1, 2022 |
- 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 [ Time Frame: baseline ]detect how many cases with vocal folds dysplasia througth comination of laryngostoboscopy and histopathology for acases of undiagnosed vocal folds irregular mucosal changes.
- to correlate between laryngostroboscopic and histopathological finding [ Time Frame: baseline ]detect to what extent using of laryngostroboscopy can give the same diagnosis of histopathology or not
| Tracking Information | |||||||||
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| First Submitted Date | June 30, 2019 | ||||||||
| First Posted Date | July 5, 2019 | ||||||||
| Last Update Posted Date | January 13, 2021 | ||||||||
| Estimated Study Start Date | February 1, 2021 | ||||||||
| Estimated Primary Completion Date | February 1, 2022 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
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 [ Time Frame: baseline ] detect how many cases with vocal folds dysplasia througth comination of laryngostoboscopy and histopathology for acases of undiagnosed vocal folds irregular mucosal changes.
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| Original Primary Outcome Measures |
measurment of prevelance vocal folds dysplasia from allcases with localized and diffuse vocal folds irregularites in Assiut university phoniatric unit within the year of study [ Time Frame: baseline ] detect how many cases with vocal folds dysplasia througth comination of laryngostoboscopy and histopathology for acases of undiagnosed vocal folds irregularites
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| Change History | |||||||||
| Current Secondary Outcome Measures |
to correlate between laryngostroboscopic and histopathological finding [ Time Frame: baseline ] detect to what extent using of laryngostroboscopy can give the same diagnosis of histopathology or not
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| Original Secondary Outcome Measures | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | Vocal Folds Irregular Mucosal Changes: A Clinical, Pathological and Genetic Study | ||||||||
| Official Title | Vocal Folds Irregular Mucosal Changes: A Clinical, Pathological and Genetic Study | ||||||||
| Brief 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 | ||||||||
| Detailed 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 |
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| Study Type | Observational | ||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | one hundred patient with localized or diffuse vocal folds irregularites wiii be examined for primary diagnosis at the phoniatric unit of ENT department in Assiut university hospital.main symptom of all patients is dysphonia of varying degree and dauration from afew days to several months . | ||||||||
| Condition | 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.
Other Name: 1.Telescopic orolaryngoscopic: 90○ rigid telescope R wolf (445057) - storz / Hopkins, 2.Tele pack X LED TP 100 storz.c)
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| Study Groups/Cohorts | Not Provided | ||||||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Not yet recruiting | ||||||||
| Estimated Enrollment |
100 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | February 1, 2022 | ||||||||
| Estimated Primary Completion Date | February 1, 2022 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria |
inclusion criteria
exclusion criteria
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| Sex/Gender |
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| Ages | 18 Years to 70 Years (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts |
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| Listed Location Countries | Not Provided | ||||||||
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| Administrative Information | |||||||||
| NCT Number | NCT04006197 | ||||||||
| Other Study ID Numbers | Vocal folds irregular mucosa | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Amira Hafez Abdelaal, Assiut University | ||||||||
| Study Sponsor | Assiut University | ||||||||
| Collaborators | Not Provided | ||||||||
| Investigators | Not Provided | ||||||||
| PRS Account | Assiut University | ||||||||
| Verification Date | January 2021 | ||||||||
