Narrow Band Imaging (NBI) for Early Diagnosis of Oral Squamous Cell Carcinoma (OSCC) and Oral Potentially Malignant Disorders (OPMD)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 480
- Locations
- 2
- Primary Endpoint
- Detection rates of OPMD and OSCC
Study Overview
Brief Summary
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.
Detailed Description
Introduction Oral squamous cell carcinoma (OSCC) is a malignant condition arising from the mucosal lining of the mouth. It is the most frequent malignancy that affects the oral cavity, with more than 350,000 new incident cases estimated worldwide yearly, causing over 150,000 deaths in 2020.
The 5-year overall survival rate of OSCC - around 60%- has not significantly improved during the last decades, despite general clinical and therapeutic advances. Considering that patients with initial stages (I-II) of OSCC show survival rates of 80-90%, while advanced-stages (III-IV) survival stands lower than 50%, it is apparent that the overall survival low value reflects that most cases are diagnosed at advanced stages. 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) is a non-invasive imaging fiberoptic technique which allows the analysis of the thin sub-epithelial vascularisation through visual magnification. There is high scientific evidence that NBI fibroscopy facilitate early diagnosis of squamous cancers of the upper aerodigestive tract. In the oral cavity, it 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.
Materials & Methods The primary outcome of this study is a comparison of the detection rates of OSCC or an OPMD using oral examination with white light (WLOE) and Narrow Band Imaging (NBI).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Detection rates of OPMD and OSCC
Time Frame: through study completion, an average of 2 year
Comparison of detection rates WLOE vs. NBI
Secondary Outcomes
- specificity(through study completion, an average of 2 year)
- PPV(through study completion, an average of 2 year)
- sensitivity(through study completion, an average of 2 year)
- NPV(through study completion, an average of 2 year)
Investigators
Agostino Guida
Consultant
Cardarelli Hospital