About this trial
Nasopharyngeal carcinoma (NPC) occurs at a high frequency in southern China, northern Africa, and Alaska, with a reported incidence of 30 cases per 100 000 in Guangdong Province. Endoscopic examination and biopsy are the main methods used for detection and diagnosis of NPC. Early NPC patients achieve favourable prognoses after concurrent radiotherapy and chemotherapy in compassion with advanced NPC patients.
Here, the investigators focused on the utility of artificial intelligence to detect early NPC, which based on white light imaging (WLI) and Narrow-band imaging (NBI) nasoendoscopic examination. Having access to this unique population provides an unprecedented opportunity to investigate the effect of intelligent system on diverse nasopharyngeal lesions detection and develop a novel Computer-Aided Diagnosis System.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Older than 18 years of age
Disqualifiers
Refuse to sign the informed consent statement
Patients who have contraindications, e.g. coagulation dysfunction, drug allergy.
Trial population
Patients at the outpatient department of otolaryngology at the First Affiliated Hospital of Sun Yat-sen University, Guangzhou, People's Republic of China, or patients at Sun Yat-Sen University Cancer Center and Kiang Wu Hospital, with risk factors including any of the following: Cantonese ethnicity, NPC family history, Epstein-Barr virus detection, any symptom of nasal obstruction, sense of peculiar smell, blood-stained nasal discharge, epistaxis, ear fullness, tinnitus, hearing loss, diplopia, headache, or cervical mass.
Trial design
Other
Prospective
Treatments tested in this trial
rigid nasal endoscopes
Diagnostic testThe endoscope is introduced through the nasal passage to observe, in sequence, the posterior nostril, superior and posterior walls of the nasopharynx, torus tubarius, pharyngeal opening of the auditory tube, and Rosenmu¨ller recess. The imaging light mode is set to conventional WLI and subsequently switch to NBI during the procedure, and representative images are collected and preserve for further analysis. All lesions, detected by either WLI or NBI, are biopsied.
Treatment groups
Trial outcomes
Primary outcomes
Pathological diagnosis
All lesions, detected by either WLI or NBI, are biopsied. 2 experienced pathologists, who were blinded to the endoscopic and intelligent assessment, evaluate the pathological nature of the biopsied lesion independently, and 2 professors with over 10 years of experience in Otolaryngology and pathology department are consulted in cases of disagreement.
Secondary outcomes
Lesion range
All images in which lesions are pathologically diagnosed as NPC are collected. 2 experienced pathologists, who were blinded to the endoscopic and intelligent assessment, delineated the malignant area in the images independently, and 2 professors with over 10 years of experience in Otolaryngology department are consulted in cases of disagreement.
Sponsors and contacts
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First Affiliated Hospital, Sun Yat-Sen University
Lead sponsor
Sun Yat-sen University
Collaborator