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.

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Key information

Conditions

Otolaryngological Disease Artificial Intelligence Carcinoma Head and Neck Neoplasms Nasopharyngeal Carcinoma Nasopharyngeal Diseases Nasopharyngeal Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pharyngeal Diseases Pharyngeal Neoplasms Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

rigid nasal endoscopes

Diagnostic Test

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.

Primary outcomes

Pathological diagnosis

Time frame: 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 outcomes

Lesion range

Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Rui He, M.D.

CONTACT

[email protected]

13096385286

Yihui Wen, Ph.D

CONTACT

[email protected]

+86-13480200660

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital, Sun Yat-Sen University

Other

Collaborators

Sun Yat-sen University

Registry information

Important dates

Study start: 2020
Primary completion: 2024
Study completion: 2026
First posted: Sep 14, 2020
Registry last updated: Feb 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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