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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04547673
Other study ID # ZSYY2020
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 20, 2020
Est. completion date December 31, 2026

Study information

Verified date February 2024
Source First Affiliated Hospital, Sun Yat-Sen University
Contact Yihui Wen, Ph.D
Phone +86-13480200660
Email wenyihui@mail.sysu.edu.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1000
Est. completion date December 31, 2026
Est. primary completion date October 31, 2024
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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


Intervention

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.

Locations

Country Name City State
China First Affiliated Hospital of Sun Yat-sen University Guangzhou Guangdong
China Sun Yat-Sen University Cancer Center Guangzhou Guangdong
China Kiang Wu Hospital Macao Macao

Sponsors (2)

Lead Sponsor Collaborator
First Affiliated Hospital, Sun Yat-Sen University Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
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