NBI for Early Diagnosis of OPMD/OSCC
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCardarelli Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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);
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Biopsy for diagnostical purposes
Other interventionIncisional 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.
Treatment groups
480 Participants
are divided into 2 treatment groupsGroup A: White Light Oral Examination (WLOE)Active comparator 1 intervention
Group B: Narrow Band Imaging (NBI)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Detection rates of OPMD and OSCC
Comparison of detection rates WLOE vs. NBI
Time frame
through study completion, an average of 2 yearSecondary outcomes
1
sensitivity
N° of true positives OSCC detected by WLOE divided by (true positives + false negatives) vs. same data for NBI
Time frame
through study completion, an average of 2 year2
specificity
n° true negatives OSCC detected by WLOE divided by (true negatives+false positives) vs. same data for NBI
Time frame
through study completion, an average of 2 year3
NPV
N° of true positives OSCC detected by WLOE divided by (true positives + false positives) vs. same data for NBI
Time frame
through study completion, an average of 2 year4
PPV
n° true negatives OSCC detected by WLOE divided by (true negatives+false negatives)vs. same data for NBI
Time frame
through study completion, an average of 2 yearSponsors and contacts
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Source ClinicalTrials.gov
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