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

Recruiting

• Conditions: Tongue Images; Gastric Cancer; Diagnosis
• Interventions: Diagnostic Test: Tongue imaging, tougue coating, saliva, and feces

• Registration Number: NCT06078930
• Lead Sponsor: Zhejiang Cancer Hospital

Brief Summary

In this study, the investigators will prospectively recruit 100,000 individuals, including gastric cancer patients who have not undergone any anti-tumor treatment and non-gastric cancer participants. The investigators 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.

Detailed Description

Patients with gastric cancer were recruited through outpatient clinics, endoscopy units, and inpatient departments of various centers, with all patients requiring a histopathological diagnosis. Non-gastric cancer participants were sourced from community health check-ups, outpatient clinics, and endoscopy units affiliated with these centers.

Study Timeline

• Study Start: 2021-06-01
• Study First Submitted: 2023-10-05
• Study First Submitted QC: 2023-10-05
• Study First Posted: 2023-10-12
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-28
• Last Update Posted: 2024-07-30
• Primary Completion: 2025-06-01
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with gastric cancer	Tongue imaging, tougue coating, saliva, and feces	-
Healthy participants	Tongue imaging, tougue coating, saliva, and feces	-

Primary Outcome Measures

Name	Time	Method
Overall Survival (OS)	5 years
The differences of the clinical information between patients with gastric cancer and healthy participants.	5 years	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.
The differences of tongue images, tongue coating, saliva, feces between patients with gastric cancer and healthy participants.	5 years

Secondary Outcome Measures

Name	Time	Method
Disease Free Survival (DFS)	5 years

Trial Locations

Locations (1)

Zhejiang Cancer Hospital; 🇨🇳 Hangzhou, Zhejiang, China