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

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.

Study Overview

• Status: Recruiting
• Conditions: Artificial Intelligence; Otolaryngological Disease
• Intervention / Treatment: Diagnostic test: rigid nasal endoscopes

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Yihui Wen, Ph.D; Phone Number: +86-13480200660; Email: wenyihui@mail.sysu.edu.cn
• Study Contact Backup: Name: Rui He, M.D.; Phone Number: 13096385286; Email: herui27@mail2.sysu.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Recruiting
      • Sun Yat-sen University Cancer Center
      • Contact: Ying Sun, Ph.D; Email: sunying@sysucc.org.cn
    • Guangzhou, Guangdong, China, 501180
      • Recruiting
      • First Affiliated Hospital of Sun Yat-sen University
      • Contact: Yihui Wen, Ph.D; Phone Number: 8613480200660; Email: wenyihui@mail.sysu.edu.cn
      • Sub-Investigator: Yudong Long, M.D.
      • Contact: Rui He, M.D.; Phone Number: 13096385286; Email: herui27@mail2.sysu.edu.cn
      • Sub-Investigator: Rui He, M.D.
  • Macao
    • Macao, Macao, China, 999078
      • Recruiting
      • Kiang Wu Hospital
      • Contact: Weijian Hou, Ph.D; Phone Number: 853-63001962; Email: houwj75@sina.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
NPC group; Patients pathologically diagnosed as NPC by agreement of 2 experienced pathologists who were blinded to the corresponding endoscopic assessment.	Diagnostic test: rigid nasal endoscopes; 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.
Non-NPC group; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: First Affiliated Hospital, Sun Yat-Sen University
• Collaborators: Sun Yat-sen University
• Investigators: Study Director: Weiping Wen, Ph.D, Otolaryngology Department, First Affiliated Hospital of Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2020
• Primary Completion (Estimated): October 31, 2024
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: September 4, 2020
• First Submitted That Met QC Criteria: September 8, 2020
• First Posted (Actual): September 14, 2020

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 16, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Endoscopy; Nasopharyngeal Carcinoma; Narrow-Band Imaging; White-Light Imaging
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Nasopharyngeal Neoplasms; Carcinoma; Nasopharyngeal Carcinoma; Otorhinolaryngologic Diseases
• Other Study ID Numbers: ZSYY2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No