Clinical trial · Interventional
NBI for Early Diagnosis of OPMD/OSCC
Narrow Band Imaging (NBI) for Early Diagnosis of Oral Squamous Cell Carcinoma (OSCC) and Oral Potentially Malignant Disorders (OPMD)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Early detection - possibly at its pre-malignant stages (Oral Potentially Malignant Disorders, OPMD) - with periodic surveillance is thus fundamental for limiting disease burden, hopefully reducing the incidence of advanced stages OSCC and increasing survival. Narrow Band Imaging (NBI) has proved itself as promising tool for helping clinician both for diagnosis and therapy. Yet, there is no definitive scientific evidence that NBI is superior to common oral examination with white light (WLOE) for diagnosing OSCC/OPMD. We thus propose a randomised clinical trial understand its role in this field.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oral Potentially Malignant Disorder | Head and Neck Squamous Cell Carcinoma | PROBABILISTIC | 0.70 |
| Oral Squamous Cell Carcinoma | Oral Cavity Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biopsy for diagnostical purposes | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- White Light Oral Examination (WLOE)
- description
- Patients will undergo commone WLOE examination prior to do a required biopsy (see protocol for patients characteristics).
- interventionNames
- Other: Biopsy for diagnostical purposes
- type
- EXPERIMENTAL
- label
- Narrow Band Imaging (NBI)
- description
- Patients will have their biopsy guided by NBI (see protocol for patients characteristics).
- interventionNames
- Other: Biopsy for diagnostical purposes
Primary outcomes (1)
- measure
- Detection rates of OPMD and OSCC
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with soft tissue, mucosal lesions of the oral cavity, who arrive for an initial first diagnosis (group 1); * Patients with history OPMD (clinically evident lesion/s group 2a, lesion/s excised group 2b), who are in follow-up (OPMDs included are eg. Leukoplakia, erythroleukoplakia, erythroplakia, oral lichen planus, oral lichenoid lesion); * Patients with history of HNSCC (OSCC group 3a, sinonasal, nasopharynx, oropharynx, larynx, oesophagus group 3b); * High risk (see above) individuals with no known oral mucosal disease (group 4); Exclusion Criteria: * patients who did not need a biopsy nor after WLOE (e.g. normal mucosa, anatomical variation) nor after NBI (pattern I) * patients who, despite indication, were not suitable to undergo biopsy given his / her systemic conditions
References
Publications (0)
Data not yet available