Combining Tongue and Gastric Cancer Cascade With Artificial Intelligence

Gastric Cancer Clinical Trial

Official title:

Analyzing the Link Between Tongue Images and Gastric Cancer Cascade Response Using Artificial Intelligence Techniques

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05368636
• Other study ID #: 2022SDU-QILU-G001
• Status: Not yet recruiting
• Start date: June 30, 2022
• Est. completion date: June 30, 2025

Study information

• Verified date: June 2022
• Source: Shandong University
• Contact: Xiuli Zuo, MD, PhD
• Phone: 86 15588818685
• Email: zuoxiuli[@]sdu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study combines artificial intelligence with tongue images, by collating and collecting tongue images and diagnostic and pathological results of gastroscopic diseases, mining and analysing the correlation between tongue images and OLGA, OLGIM stages, Correa sequences and constructing prediction models, to deeply investigate the relationship between tongue images and precancerous diseases, precancerous lesions and gastric cancer.

Description:

Firstly, tongue pictures and patient information will be collected after the patient signed an informed consent form.

Secondly, after the patient undergoes gastroscopy, patient gastroscopy reports and pathology reports will be obtained.

Thirdly, the investigator will assess the patient's gastroscopy report for the Correa sequence of gastric cancer with OLGA and OLGIM staging.

Finally, the patient's tongue image, information and gastric cancer cascade response are matched to construct an artificial intelligence model and assess the quality of the model.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 4000
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients between 40 and 80 years of age who are scheduled for gastroscopy.

• Patients all gave their informed consent and signed the informed consent form.

Exclusion Criteria:

• Persons with severe cardiac, cerebral, pulmonary or renal dysfunction or psychiatric disorders who are unable to participate in gastroscopy.

• Patients with previous surgical procedures on the gastrointestinal tract.

• Patients taking bismuth or other staining drugs.

Related Conditions & MeSH terms

• Artificial Intelligence
• Gastric Cancer
• Stomach Neoplasms

Locations

Country	Name	City	State
China	Qilu hosipital	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity	Sensitivity of artificial intelligence models Sensitivity = number of true positives / (number of true positives + number of false negatives) * 100%.	3 years
Primary	Specificity	Specificity of Artificial Intelligence Models Specificity = number of true negatives / (number of true negatives + number of false positives))*100%	3 years
Primary	Positive predictive values(PPV)	Positive predictive values from artificial intelligence models Positive predictive value = true positive / (true positive + false positive)*100%	3 years
Primary	Negative predictive values(NPV)	Negative predictive values for artificial intelligence models Negative predictive value = true negative / (true negative + false negative)*100%	3 years
Primary	AUC (95% CI)	area under the receiver operating characteristic curve (AUC)	3 years
Primary	Accuracy	Accuracy of artificial intelligence models Accuracy = (true positives + true negatives) / total number of subjects * 100%	3 years