Narrow band imaging in head and neck cancer

Establishing the diagnostic and prognostic role of narrow band imaging in head and neck cancer

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON27129

Enrollment

600

Registered

2016-11-03

Start date

2015-09-10

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Observational cohort study, partially randomized controlled sub-studies. The intervention itself is not part of the study.

Eligibility

Inclusion criteria

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

Exclusion criteria: none

Design outcomes

Primary

Measure	Time frame
- Correlation between WLI and / or NBI with histopathological diagnosis. - Accuracy: percentage of true results = (true positives + true negatives)/ total results.	—

Secondary

Measure	Time frame
there are 6 different substudies. Every study has its own secondary outcomes. 4 secondary goals are: 1. To identify NBI + WLI as superior to WLI alone in the early detection of local HNC recurrences after first line treatment 2. To identify NBI + WLI as a better diagnostic and staging tool in the determination of tumor field and as a consequence tumor staging than WLI alone 3. To conclude that inter-observer and intra-observer variability/reliability in the visual analysis of benign and (pre) malignant lesions in the upper aerodigestive tract is higher using NBI+WLI than WLI alone. 4. To increase reliability and decrease inter-/intra-observer variability by creating a NBIatlas which will be helpful in correct interpretation of NBI and can be used as a standard reference in ENT/head and neck oncology in order to increase earlier detection of (pre)malignant HNC lesions using NBI	—

Measure

Time frame

there are 6 different substudies. Every study has its own secondary outcomes. 4 secondary goals are: 1. To identify NBI + WLI as superior to WLI alone in the early detection of local HNC recurrences after first line treatment 2. To identify NBI + WLI as a better diagnostic and staging tool in the determination of tumor field and as a consequence tumor staging than WLI alone 3. To conclude that inter-observer and intra-observer variability/reliability in the visual analysis of benign and (pre) malignant lesions in the upper aerodigestive tract is higher using NBI+WLI than WLI alone. 4. To increase reliability and decrease inter-/intra-observer variability by creating a NBIatlas which will be helpful in correct interpretation of NBI and can be used as a standard reference in ENT/head and neck oncology in order to increase earlier detection of (pre)malignant HNC lesions using NBI

—

Contacts

Public ContactM.A. Zwakenberg

Hanzeplein 1

m.a.zwakenberg@umcg.nl050 3612540

Outcome results