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

Recruiting

• Conditions: Artificial Intelligence; Otolaryngological Disease
• Interventions: Diagnostic Test: rigid nasal endoscopes

• Registration Number: NCT04547673
• Lead Sponsor: First Affiliated Hospital, Sun Yat-Sen University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-20
• Study First Submitted: 2020-09-04
• Study First Submitted QC: 2020-09-08
• Study First Posted: 2020-09-14
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-16
• Last Update Posted: 2024-02-20
• Primary Completion: 2024-10-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non-NPC group	rigid nasal endoscopes	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.
NPC group	rigid nasal endoscopes	Patients pathologically diagnosed as NPC by agreement of 2 experienced pathologists who were blinded to the corresponding endoscopic assessment.

Primary Outcome Measures

Name	Time	Method
Pathological diagnosis	baseline	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 Outcome Measures

Name	Time	Method
Lesion range	baseline	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.

Trial Locations

Locations (3)

First Affiliated Hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China

Kiang Wu Hospital; 🇨🇳 Macao, Macao, China

Sun Yat-Sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China