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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFirst Affiliated Hospital, Sun Yat-Sen University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Older than 18 years of age

Disqualifiers

Refuse to sign the informed consent statement

Patients who have contraindications, e.g. coagulation dysfunction, drug allergy.

Trial 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.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

1,000 Participants
are divided into 2 treatment groups
Group A: NPC group1 intervention
Group B: Non-NPC group1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
baseline

Secondary outcomes

1

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.

Time frame
baseline

Other outcomes

Sponsors and contacts

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