NCT04006197

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 30, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 5, 2019

Completed
1.7 years until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

January 6, 2026

Status Verified

January 1, 2026

Enrollment Period

2.4 years

First QC Date

June 30, 2019

Last Update Submit

January 2, 2026

Conditions

Vocal Cord Neoplasm

Keywords

vocal folds dysplasia

Outcome Measures

Primary Outcomes (1)

  • Correlation between video-stroboscopic examination and histopathological results

    Correlation between video-stroboscopic examination and histopathological groups.

    baseline

Secondary Outcomes (1)

  • to correlate between SOX2 gene expression and histopathological finding

    baseline

Interventions

laryngostroboscopy and histoh-pathologyOTHER

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.

Also known as: 1.Telescopic orolaryngoscopic: 90○ rigid telescope R wolf (445057) - storz / Hopkins, 2.Tele pack X LED TP 100 storz.c)

Eligibility Criteria

Age18 Years - 70 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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 .

You may qualify if:

  • Age 18-70 years old males
  • Unilateral or bilateral localized and diffuse vocal fold irregularities.
  • Patients with white (leukoplakia) patches on one or both vocal folds
  • No previous microphonosurgery.
  • No previous history of radiotherapy .6.No impairment of the vocal fold mobility.

You may not qualify if:

  • Subject refusal.
  • Patients with large exophytic and/or ulcerated mass.
  • Vocal fold cysts or polyps, contact granulomas, or Reinke's edema
  • If there is a concern for rapid growth pattern, airway obstruction requiring urgent operative intervention
  • Vocal fold immobility
  • History of allergies and GERD.
  • Unfit for general anesthesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university, faculty of medicine

Asyut, Asyut Governorate, 71515, Egypt

Location

Related 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.

    PMID: 21971762BACKGROUND

  • 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. doi: 10.1007/s00405-007-0549-9. Epub 2007 Dec 4.

    PMID: 18057948BACKGROUND

  • Sadri 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: 16823559BACKGROUND

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

June 30, 2019

First Posted

July 5, 2019

Study Start

March 1, 2021

Primary Completion

August 1, 2023

Study Completion

August 1, 2023

Last Updated

January 6, 2026

Record last verified: 2026-01

Locations

EG(1)