Development of a Machine Learning Model for Nasopharyngeal Carcinoma Screening Based on Tongue Imaging

NCT06129201 | Unknown

• 1 other identifier: ZDWY.ZYZLK.006
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

Brief Summary

Nasopharyngeal cancer is common in China, Southeast Asia, and North Africa, and is usually associated with Epstein-Barr virus (EBV) infection. Using EBV specific antibodies or EBV DNA screening can increase the proportion of patients diagnosed with early nasopharyngeal carcinoma from approximately 20% to over 70%. However, the application of nasopharyngeal carcinoma screening in clinical practice is hindered by low positive predictive values, even in areas where the EB virus is prevalent in China, the positive predictive value is only 4.8%. Therefore, there is an urgent need to identify new biomarkers or strategies with high sensitivity and positive predictive value for nasopharyngeal carcinoma screening. A study published in the Lancet sub journal 《eClinicalMedicine》 in 2023 showed that a tongue image model based on machine learning can serve as a stable diagnostic method for gastric cancer (AUC=0.89), and has been clinically validated in multiple centers. This study inspires researchers to introduce artificial intelligence machine learning technology into the diagnosis and treatment of nasopharyngeal cancer. In summary, this plan explores the establishment of tongue image machine learning models in nasopharyngeal carcinoma patients to help improve the positive predictive value of nasopharyngeal carcinoma screening.

Conditions

Nasopharyngeal Carcinoma

Keywords

Artificial Intelligence， Tongue Image

Outcome Measures

Primary Outcomes (1)

• Area Under Curve (AUC) of Diagnostic Model

  Determine the screening effectiveness of the nasopharyngeal carcinoma tongue image model

  12 months

Study Arms (2)

Training group

Experimental group: population of initially diagnosed nasopharyngeal carcinoma \[600 people\]; Control group: 2400 healthy individuals+nasopharyngeal disease patients+other tumors.

Other: Tongue image

Validation group

Validation group: Experimental group: Nasopharyngeal cancer population \[400 people\]; Control group: 1600 healthy individuals+patients with nasopharyngeal diseases+other tumors.

Other: Tongue image

Interventions

Tongue image OTHER

Using intelligent imaging devices to collect subject tongue images

Training group; Validation group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study plans to include a training group consisting of 600 newly diagnosed nasopharyngeal carcinoma patients and 800 healthy individuals, as well as 800 individuals with common nasopharyngeal diseases and other tumors. According to the training group: validation group=6:4, configure the number of validation group members. There are approximately 5000 people in total.

You may qualify if:

• Cancer patients confirmed by histology/cytology
• Patients with nasopharyngeal carcinoma in the training group are initially diagnosed
• Subjects voluntarily participate in the study

You may not qualify if:

• Subjects taking medication or diet may affect their tongue image (such as aluminum magnesium carbonate, traditional Chinese medicine rhubarb, etc.)
• The researchers determined that the subjects had other factors that could force them to terminate the study.

Sponsors & Collaborators

• Fifth Affiliated Hospital, Sun Yat-Sen University: lead

Study Sites (1)

The Fifth Affiliated Hospital of Sun Yat sen University

Zhuhai, China

Location

Related Publications (16)

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MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Study Officials

• Qi Zeng, Doctor

  Fifth Affiliated Hospital, Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yulong Zhang, Doctor

CONTACT

18810550602; zhongxiyi1101@163.com

Study Design

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

Study Record Dates

• First Submitted: November 2, 2023
• First Posted: November 13, 2023
• Study Start: November 15, 2023
• Primary Completion: November 15, 2024
• Study Completion: December 1, 2025
• Last Updated: November 13, 2023

Record last verified: 2023-11

Locations

CN (1)