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
Trial ID: NCT06078930
Status: RECRUITING
Study type: OBSERVATIONAL
Start date: 2021-06-01
Completion date: 2026-12-31
Sponsor: Zhejiang Cancer Hospital
Collaborators: Sichuan Cancer Hospital and Research Institute; The First Affiliated Hospital of Zhejiang Chinese Medical University; Wenzhou Medical University; Fujian Cancer Hospital; RenJi Hospital; Zhejiang Provincial Tongde Hospital; Kecheng District People's Hospital; Yueyang Central Hospital; Shandong Cancer Hospital and Institute; Shanxi Province Cancer Hospital; Liaoning Cancer Hospital & Institute; Harbin Cancer Hospital; Yuhang District People's Hospital; Hainan Cancer Hospital; Zigong Fourth People's Hospital; Henan University of Science and Technology; Shangyu People's Hospital of Shaoxing City; Red Cross Hospital, Hangzhou, China; The Affiliated Hospital of Hangzhou Normal University; Xiaoshan District First People's Hospital; Xianju People's Hospital; Lin'an District First People's Hospital; First Affiliated Hospital of Wenzhou Medical University; Wenzhou Central Hospital; The Third Affiliated Hospital of Wenzhou Medical University; Leqing City People's Hospital; The Affiliated Hospital of Medical School of Ningbo University; Cixi City People's Hospital; Mingzhou Hospital, Zhejiang University; Fourth Hospital of Ningbo City; Fenghua District People's Hospital; Fenghua Traditional Chinese Medicine Hospital, Ningbo City; Xikou Hospital, Fenghua District, Ningbo City; Chengdu University of Traditional Chinese Medicine; Guang'an Hospital, Affiliated to Chengdu University of Traditional Chinese Medicine; Jiangsu Cancer Institute & Hospital; Jiangsu Provincial People's Hospital; The First People's Hospital of Changzhou; The First Affiliated Hospital of Soochow University; Jiangsu Province Hospital of Traditional Chinese Medicine; Zidong Campus of Jiangsu Provincial Hospital of TCM; Wuxi Traditional Chinese Medicine Hospital; First Affiliated Hospital of Harbin Medical University; The First Affiliated Hospital of Anhui Medical University; Peking University Cancer Hospital & Institute; Xijing Hospital; Guangdong Provincial Hospital of Traditional Chinese Medicine; Xiangya Hospital of Central South University; Yunnan Cancer Hospital; Chongqing University Cancer Hospital; Gansu Cancer Hospital; Fudan University; Cancer Institute and Hospital, Chinese Academy of Medical Sciences; First Affiliated Hospital of Guangxi Medical University; Tianjin Medical University Cancer Institute and Hospital; Huzhou Central Hospital; Zhoushan Hospital, Zhejiang
Conditions: Gastric Cancer; Tongue Images; Diagnosis
Interventions: Tongue imaging, tougue coating, saliva, gastric juice, and feces
Locations: Zhejiang Cancer Hospital
Countries: China
Enrollment: 100000
Age range: 18 Years - 90 Years
Sex: ALL

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.

Eligibility 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

Outcomes:
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.; The differences of the clinical information between patients with gastric cancer and healthy participants.; Overall Survival (OS)