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

University of Chinese Academy Sciences

Status

Enrolling

Conditions

Gastric Cancer

Diagnosis

Tongue Images

Treatments

Diagnostic Test: Tongue imaging, tougue coating, saliva, gastric juice, and feces

Study type

Observational

Funder types

Other

Identifiers

NCT06078930

IRB-2021-289

Details and patient eligibility

About

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.

Full 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.

Enrollment

100,000 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

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