Biopsy for diagnostical purposes: Incisional biopsy is the current golden standard for OPMD/OSCC diagnosis. Yet, the site it shall be performed is choosen by clinician at naked eyes. We will compare and study the results of performing the common golden standard biopsy site when guided by NBI.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
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
Primary outcome measure(s)
Detection rates of OPMD and OSCC — through study completion, an average of 2 year Comparison of detection rates WLOE vs. NBI
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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