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

Development of a Machine Learning Model for Nasopharyngeal Carcinoma Screening Based on Tongue Imaging: a Prospective Multicenter Cross-sectional Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06129201
Enrollment
5000
Registered
2023-11-13
Start date
2023-11-15
Completion date
2025-12-01
Last updated
2023-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nasopharyngeal Carcinoma

Keywords

Artificial Intelligence, Tongue Image

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.

Detailed description

Nasopharyngeal cancer is common in China, Southeast Asia, and North Africa, and is generally 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%. In previous studies, researchers found that participants who underwent screening were more likely to achieve long-term survival after being diagnosed with nasopharyngeal carcinoma compared to the control group, and the risk of nasopharyngeal carcinoma specific death was lower among screened patients (relative risk 0.22). 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%. More than 95% of high-risk participants identified through primary serological screening underwent unnecessary and time-consuming clinical examinations and follow-up. The combination of various biomarkers, multi-step screening, and identification of new biomarkers are used to improve the performance of nasopharyngeal cancer screening strategies. However, the progress achieved so far is still unsatisfactory, characterized by low sensitivity, complex operation, or high cost. Therefore, there is an urgent need to identify new biomarkers or strategies with high sensitivity and positive predictive value for nasopharyngeal carcinoma screening. In 《The New England Journal of Medicine》 in 2023, Professor Xia Ningshao's team reported on the identification and validation of anti BNLF2 total antibody (P85Ab) as a new serological biomarker for nasopharyngeal cancer screening.The sensitivity of P85-Ab nasopharyngeal carcinoma is 97.9%, with a positive predictive value of 10.0%. Furthermore, on the basis of P85-Ab positivity, if further detection of EB double antibodies (EBV nuclear antigen 1 \[EBNA1\]-IgA and EBV-specific viral capsid antigen \[VCA\]-IgA) is carried out, intermediate or medium high risk individuals with EB double antibodies can undergo nasopharyngoscopy examination, which can increase the positive predictive value of nasopharyngeal carcinoma screening to 29.6% -44.6%, that is, for every 2-3 nasopharyngoscopes performed, one case of nasopharyngeal carcinoma can be diagnosed. The sensitivity of this study is very high, but the positive predictive value is only 10%. Even when combined with traditional EB dual antibody monitoring and nasal endoscopy, one-third to one-half of non nasopharyngeal carcinoma patients still undergo unnecessary and time-consuming clinical examinations. Therefore, it is still necessary to explore simple and cost-effective methods to improve the strategy of 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.

Interventions

Using intelligent imaging devices to collect subject tongue images

Sponsors

Fifth Affiliated Hospital, Sun Yat-Sen University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Area Under Curve (AUC) of Diagnostic Model12 monthsDetermine the screening effectiveness of the nasopharyngeal carcinoma tongue image model

Countries

China

Contacts

Primary ContactYulong Zhang, Doctor
zhongxiyi1101@163.com18810550602

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026