AI System for Anatomic Recognition & Lesion Detection in Nasopharyngolaryngoscopy: A Prospective Study

NCT07326358 | Recruiting

• 1 other identifier: 2025-811
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

An artificial intelligence-assisted system is trained and validated by collecting nasopharyngolaryngoscopy images from patients.

Conditions

Nasopharyngeal Neoplasms; Laryngeal Disease

Outcome Measures

Primary Outcomes (2)

• performance of lesion detection

  The area under the receiver operating characteristic curve (ROC-AUC) of the model for abnormal lesion detection

  Within 3 months after the completion of prospective data collection

• performance of anatomic site recognition

  The average precision (AP) of the model for recognizing nasopharyngeal and laryngeal anatomic sites

  Within 3 months after the completion of prospective data collection

Secondary Outcomes (1)

• Comparison of diagnostic performance between the model and physicians

  Within 3 months after the completion of prospective data collection

Study Arms (2)

Model training and validation cohorts

A deep learning model is trained using the training dataset and validated with the internal validation set.

Other: Diagnostic

Prospective test cohort

Patients are prospectively enrolled, nasopharyngolaryngoscopy examination videos are collected, and the video data are processed to form a prospective test dataset, which is then used for testing.

Other: Diagnostic

Interventions

Diagnostic OTHER

The deep learning model is trained using the training dataset and tested with the internal validation set.

Model training and validation cohorts

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Image data of patients who underwent nasopharyngolaryngoscopy and met the research requirements were collected from various sub-centers nationwide.

You may qualify if:

• Age ≥ 18 years;
• Underwent standard electronic nasopharyngolaryngoscopy;
• Patients who underwent biopsy sampling have a clear pathological diagnosis;
• Signed a written informed consent form.

You may not qualify if:

• Image quality is substandard with severe motion artifacts;
• Lesion images are unclear and incomplete.

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Neoplasms; Laryngeal Diseases

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Respiratory Tract Diseases

Central Study Contacts

Bin Ye, MD PhD

CONTACT

+8615216616895; aydyebin@126.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2025
• First Posted: January 8, 2026
• Study Start: December 12, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: January 8, 2026

Record last verified: 2025-12

Locations

CN (1)