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Clinical Trials/NCT04547673
NCT04547673
Recruiting
Not Applicable

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

First Affiliated Hospital, Sun Yat-Sen University3 sites in 1 country1,000 target enrollmentJune 20, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Otolaryngological Disease
Sponsor
First Affiliated Hospital, Sun Yat-Sen University
Enrollment
1000
Locations
3
Primary Endpoint
Pathological diagnosis
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 20, 2020
End Date
December 31, 2026
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
First Affiliated Hospital, Sun Yat-Sen University
Responsible Party
Principal Investigator
Principal Investigator

Weiping Wen

Vice President of First Affiliated Hospital, Sun Yat-Sen University; President of sixth Affiliated Hospital, Sun Yat-Sen University

First Affiliated Hospital, Sun Yat-Sen University

Eligibility Criteria

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.

Outcomes

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(baseline)

Study Sites (3)

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