To Develop and Validate a Nasoendoscopic Intelligent Diagnostic System for Nasopharyngeal Carcinoma

Study Overview
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Brief Summary
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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.

Official Title
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To Develop and Validate a Nasoendoscopic Intelligent Diagnostic System for Nasopharyngeal Carcinoma

Conditions
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Otolaryngological Disease, Artificial Intelligence

Intervention / Treatment
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* Diagnostic Test: rigid nasal endoscopes


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Older than 18 years of age Exclusion Criteria: Refuse to sign the informed consent statement Patients who have contraindications, e.g. coagulation dysfunction, drug allergy.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| NPC group<br>Patients pathologically diagnosed as NPC by agreement of 2 experienced pathologists who were blinded to the corresponding endoscopic assessment. | Diagnostic Test: rigid nasal endoscopes<br>* The 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.<br>|
| Non-NPC group<br>Patients pathologically diagnosed as non-NPC (including inflammatory hyperplasia, Atypical hyperplasia, Papilloma etc.) by agreement of 2 experienced pathologists who were blinded to the corresponding endoscopic assessment. | Diagnostic Test: rigid nasal endoscopes<br>* The 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nasopharyngeal Carcinoma, Endoscopy, Narrow-Band Imaging, White-Light Imaging