Development of Novel Gastric Cancer Screening and Diagnosis Technologies Using Tongue Imaging and Study of Tongue Image Changes Mechanisms

Study Overview
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Brief Summary
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In this study, we will prospectively recruit 100,000 individuals, including gastric cancer patients who have not undergone any anti-tumor treatment and non-gastric cancer participants. We will construct a diagnostic model for malignant tumors based on the combination of tongue imaging, tongue coating, saliva, and fecal multi-omics data (including metagenomics, proteomics, metabolomics, etc.). Additionally, it will explore the relationship between oral and intestinal microbiota and the development of malignant tumors.

Official Title
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A Multi-center Observational Clinical Study on the Development of Artificial Intelligence-Based Gastric Cancer Screening and Diagnosis Technology Using Multi-Omics Analysis of Tongue Imaging and Tongue Coating

Conditions
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Gastric Cancer, Tongue Images, Diagnosis

Intervention / Treatment
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* Diagnostic Test: Tongue imaging, tougue coating, saliva, and feces


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria for Gastric Cancer Patients: 18≤age≤80 Histologically or cytologically confirmed gastric cancer No prior chemotherapy, radiotherapy, biotherapy, immunotherapy or other anti-tumor treatment for gastric cancer Subject volunteers to join the study, Signs informed consent, has good compliance and can cooperate with follow-up Exclusion Criteria for Gastric Cancer Patients: Two or more kinds of malignant tumors at the same time Gastric cancer that has been treated by chemotherapy, radiotherapy, biotherapy, immunotherapy or other anti-tumor therapy The use of glucocorticoids and antibiotics in the past three months History of long-term medication Presence of oral diseases such as tooth and gum diseases Subjects who had other factors that might force them to terminate the research ahead of time, such as the development of other severe disease (including mental disease) that required combined treatment, seriously abnormal laboratory examination value, and family or social factors that might affect the subject safety or experimental data collection, as judged by the researchers Inclusion Criteria for Healthy Participants: 18≤age≤80 Willingness to participate in the study, signing an informed consent form, and demonstrating good compliance Exclusion Criteria for Healthy Participants: History of malignant tumors The use of glucocorticoids and antibiotics in the past three months History of long-term medication Presence of oral diseases such as tooth and gum diseases Subjects who had other factors that might force them to terminate the research ahead of time, such as the development of other severe disease (including mental disease) that required combined treatment, seriously abnormal laboratory examination value, and family or social factors that might affect the subject safety or experimental data collection, as judged by the researchers

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with gastric cancer<br> | Diagnostic Test: Tongue imaging, tougue coating, saliva, and feces<br>* Tongue images, coating, saliva, and feces on the tongue and clinical data of patients with gastric cancer and healthy participants will be collected.<br>|
| Healthy participants<br> | Diagnostic Test: Tongue imaging, tougue coating, saliva, and feces<br>* Tongue images, coating, saliva, and feces on the tongue and clinical data of patients with gastric cancer and healthy participants will be collected.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The differences of tongue images, tongue coating, saliva, feces between patients with gastric cancer and healthy participants. |  | 5 years | 
| The differences of the clinical information between patients with gastric cancer and healthy participants. | These data of gastric cancer group included age, sex, height, weight, family history, smoking, drinking, TNM staging, tumor location, tumor size, pathological type, grade of differentiation, expression of Her2, nerve invasion, vascular tumor thrombus, lauren type and and blood tumour markers, and these data of healthy participants group included age, sex, height, weight, smoking, drinking and blood tumour markers. | 5 years | 
| Overall Survival (OS) |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Free Survival (DFS) |  | 5 years |