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

NCT ID: NCT04547673

Last Updated: 2024-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-20

Study Completion Date

2026-12-31

Brief Summary

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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

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Conditions

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Otolaryngological Disease Artificial Intelligence

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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NPC group

Patients pathologically diagnosed as NPC by agreement of 2 experienced pathologists who were blinded to the corresponding endoscopic assessment.

rigid nasal endoscopes

Intervention Type 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.

Non-NPC group

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.

rigid nasal endoscopes

Intervention Type 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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role collaborator

First Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role lead

Responsible Party

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Weiping Wen

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

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Weiping Wen, Ph.D

Role: STUDY_DIRECTOR

Otolaryngology Department, First Affiliated Hospital of Sun Yat-sen University

Locations

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First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status RECRUITING

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, China

Site Status RECRUITING

Kiang Wu Hospital

Macao, Macao, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yihui Wen, Ph.D

Role: CONTACT

+86-13480200660

Rui He, M.D.

Role: CONTACT

13096385286

Facility Contacts

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Yihui Wen, Ph.D

Role: primary

8613480200660

Rui He, M.D.

Role: backup

13096385286

Ying Sun, Ph.D

Role: primary

Weijian Hou, Ph.D

Role: primary

853-63001962

References

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He R, Jie P, Hou W, Long Y, Zhou G, Wu S, Liu W, Lei W, Wen W, Wen Y. Real-time artificial intelligence-assisted detection and segmentation of nasopharyngeal carcinoma using multimodal endoscopic data: a multi-center, prospective study. EClinicalMedicine. 2025 Feb 15;81:103120. doi: 10.1016/j.eclinm.2025.103120. eCollection 2025 Mar.

Reference Type DERIVED
PMID: 40026832 (View on PubMed)

Other Identifiers

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ZSYY2020

Identifier Type: -

Identifier Source: org_study_id

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