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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06078930

Enrollment

100000

Registered

2023-10-12

Start date

2021-06-01

Completion date

2026-12-31

Last updated

2025-06-04

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

Conditions

Diagnosis, Gastric Cancer, Tongue Images

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, gastric juice, and fecal multi-omics data (including metagenomics, proteomics, metabolomics, etc.). Additionally, the study will explore the relationship between oral, gastric, 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.

Interventions

DIAGNOSTIC_TESTTongue imaging, tougue coating, saliva, gastric juice, and feces

Tongue images, coating, saliva, gastric juice, and feces on the tongue and clinical data of patients with gastric cancer and healthy participants will be collected.

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

Yes

Inclusion criteria

for Gastric Cancer Patients: * 18≤age≤90 * 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≤90 * Willingness to participate in the study, signing an informed consent form, and demonstrating good compliance

Design outcomes

Primary

Measure	Time frame	Description
The differences in tongue images, tongue coating, saliva, gastric juice, and fecal samples between patients with gastric cancer and healthy individuals will be systematically analyzed.	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.
Overall Survival (OS)	5 years	—

Secondary

Measure	Time frame
Disease Free Survival (DFS)	5 years

Countries

China

Contacts

Primary ContactXiangdong Cheng, MD

Chengxd516@126.com0086-571-88128041

Backup ContactZhiyuan Xu, MD

getfar@foxmai.com0086-571-88128041

Outcome results

None listed

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