Late radiation effects, leukoplakia, papilloma, squamous cell carcinoma and healthy vocal cords . Radiotherapy, leukoplakia, papilloma, cancer and healthy vocal cords.
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: The aim is to include 60 study participants in the following five different categories: - Squamous cell carcinoma on the vocal cords (n=8) - leukoplakia on the vocal cords (n=8) - late radiation effects on vocal cords (n=8) - papilloma on vocal cords (n=8) - healthy vocal cords (n=8). The number of study participants (60) is larger than the minimal required number of participants (40) to compensate for recorded video's that appear to be unsuitable for this research project. Older than the age of 18 years and competent. Although pregnant or breastfeeding woman may be included, there is no need to ask or register anything about pregnancy or breastfeeding. There is no reason to exclude participants elder than the age of 64 years, but participants should understand the general concept and the additional burden of this study and consent.
Exclusion criteria
Exclusion criteria: Below the age of 18 years or incapable of giving informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Image sharpness expressed as MTF50. Diagnostic accuracy expressed as the percentage of videos assessed correctly. | — |
Secondary
| Measure | Time frame |
|---|---|
| - sensitivity, specificity, positve predictive value and negative predictive value per pathology (4 pathologies). - sensitivity, specificity, positve predictive value and negative predictive value disease versus non-disease. | — |
Countries
Netherlands
Contacts
Erasmus MC, Universitair Medisch Centrum Rotterdam