ESTABLISHING THE DIAGNOSTIC AND PROGNOSTIC ROLE OF NARROW BAND IMAGING IN HEAD AND NECK CANCER
Completed
- Conditions
- head and neck cancerHNSCC10027655
- Registration Number
- NL-OMON47793
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 450
Inclusion Criteria
- suspicion of or proven carcinoma of the oral cavity, nasal cavity, pharynx or
larynx.
- suspicion of a benign lesion of the larynx
- > 18 yrs of age
- informed consent
Exclusion Criteria
none
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary Objective: to validate NBI (using flexible and rigid laryngosopes) in<br /><br>HNC as a prognosticator and establish NBI as a reliable diagnostic tool by<br /><br>discriminating (pre)malignant lesions from benign lesions</p><br>
- Secondary Outcome Measures
Name Time Method <p>1. To identify NBI + WLI as superior to WLI alone in the early detection of<br /><br>local HNC recurrences after first line treatment<br /><br>2. To identify NBI + WLI as a better diagnostic and staging tool in the<br /><br>determination of tumor field and as a consquence tumor staging than WLI alone<br /><br>3. To conclude that inter-observer and intra-observer variability/reliability<br /><br>in the visual analysis of benign and (pre) malignant lesions in the upper<br /><br>aerodigestive tract is higher using NBI+WLI than WLI alone.<br /><br>4. To increase reliability and decrease inter-/intra-observer variability by<br /><br>creating a NBI-atlas which will be helpful in correct interpretation of NBI.</p><br>