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

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.

Study Overview

• Status: Recruiting
• Conditions: Gastric Cancer; Diagnosis; Tongue Images
• Intervention / Treatment: Diagnostic test: Tongue imaging, tougue coating, saliva, and feces

• Study Type: Observational
• Enrollment (Estimated): 100000

Contacts and Locations

• Study Contact: Name: Xiangdong Cheng, MD; Phone Number: 0086-571-88128041; Email: Chengxd516@126.com
• Study Contact Backup: Name: Zhiyuan Xu, MD; Phone Number: 0086-571-88128041; Email: getfar@foxmai.com

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310022
      • Recruiting
      • Zhejiang Cancer Hospital
      • Contact: Cheng Xiangdong, MD; Phone Number: +0086-571-88128041; Email: Chengxd516@126.com
      • Contact: Zhiyuan Xu; Phone Number: 0086-571-88128041; Email: getfar@foxmai.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Histologically or cytologically confirmed gastric cancer, and no prior chemotherapy, radiotherapy, biotherapy, immunotherapy or other anti-tumor treatment for malignant tumor. Gastric cancer patients and healthy participants should not have the following conditions: the use of glucocorticoids and antibiotics in the past three months, a history of long-term medication, as well as oral diseases such as tooth and gum diseases.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy participants	Diagnostic test: Tongue imaging, tougue coating, saliva, and feces; Tongue images, coating, saliva, and feces on the tongue and clinical data of patients with gastric cancer and healthy participants will be collected.
Patients with gastric cancer	Diagnostic test: Tongue imaging, tougue coating, saliva, and feces; Tongue images, coating, saliva, and feces on the tongue and clinical data of patients with gastric cancer and healthy participants will be collected.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)		5 years
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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Zhejiang Cancer Hospital
• Collaborators: Wenzhou Medical University; Xijing Hospital; Shanxi Province Cancer Hospital; The First Affiliated Hospital of Anhui Medical University; Chongqing University Cancer Hospital; Guangdong Provincial Hospital of Traditional Chinese Medicine; Xiangya Hospital of Central South University; Fudan University; Cancer Institute and Hospital, Chinese Academy of Medical Sciences; Shanghai Zhongshan Hospital; Fujian Cancer Hospital; RenJi Hospital; Peking University Cancer Hospital & Institute; Chengdu University of Traditional Chinese Medicine; Shandong Cancer Hospital and Institute; The First Affiliated Hospital of Soochow University; Jiangsu Cancer Institute & Hospital; Red Cross Hospital, Hangzhou, China; The Affiliated Hospital of Medical School of Ningbo University; First Affiliated Hospital of Wenzhou Medical University; Wenzhou Central Hospital; Huizhou Municipal Central Hospital; Liaoning Tumor Hospital & Institute; First Affiliated Hospital of Harbin Medical University; Sichuan Cancer Hospital and Research Institute; Yunnan Cancer Hospital; The First People's Hospital of Changzhou; Jiangsu Provincial People's Hospital; The First Affiliated Hospital of Zhejiang Chinese Medical University; First Affiliated Hospital of Guangxi Medical University; Tianjin Medical University Cancer Institute & Hospital; Gansu Cancer Hospital; Yueyang Central Hospital; Hainan Cancer Hospital; Cixi City People's Hospital; Shangyu People's Hospital of Shaoxing City; Xianju County People's Hospital; Ruian City People's Hospital; Henan University of Science and Technology; Tongde Hospital of Zhejiang; Kecheng District People's Hospital; Harbin Cancer Hospital; Yuhang District People's Hospital; Zigong Fourth People's Hospital; Hangzhou Normal University Affiliated Hospital; Xiaoshan District First People's Hospital; Lin'an District First People's Hospital; Leqing 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; Guang'an Hospital, Affiliated to Chengdu University of Traditional Chinese Medicine; Jiangsu Provincial Hospital of Traditional Chinese Medicine; Zidong Campus of Jiangsu Provincial Hospital of TCM; Wuxi Traditional Chinese Medicine Hospital

Publications and helpful links

General Publications

• Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
• Yuan L, Yang L, Zhang S, Xu Z, Qin J, Shi Y, Yu P, Wang Y, Bao Z, Xia Y, Sun J, He W, Chen T, Chen X, Hu C, Zhang Y, Dong C, Zhao P, Wang Y, Jiang N, Lv B, Xue Y, Jiao B, Gao H, Chai K, Li J, Wang H, Wang X, Guan X, Liu X, Zhao G, Zheng Z, Yan J, Yu H, Chen L, Ye Z, You H, Bao Y, Cheng X, Zhao P, Wang L, Zeng W, Tian Y, Chen M, You Y, Yuan G, Ruan H, Gao X, Xu J, Xu H, Du L, Zhang S, Fu H, Cheng X. Development of a tongue image-based machine learning tool for the diagnosis of gastric cancer: a prospective multicentre clinical cohort study. EClinicalMedicine. 2023 Feb 6;57:101834. doi: 10.1016/j.eclinm.2023.101834. eCollection 2023 Mar.
• Wang FH, Zhang XT, Li YF, Tang L, Qu XJ, Ying JE, Zhang J, Sun LY, Lin RB, Qiu H, Wang C, Qiu MZ, Cai MY, Wu Q, Liu H, Guan WL, Zhou AP, Zhang YJ, Liu TS, Bi F, Yuan XL, Rao SX, Xin Y, Sheng WQ, Xu HM, Li GX, Ji JF, Zhou ZW, Liang H, Zhang YQ, Jin J, Shen L, Li J, Xu RH. The Chinese Society of Clinical Oncology (CSCO): Clinical guidelines for the diagnosis and treatment of gastric cancer, 2021. Cancer Commun (Lond). 2021 Aug;41(8):747-795. doi: 10.1002/cac2.12193. Epub 2021 Jul 1.
• Li MY, Zhu DJ, Xu W, Lin YJ, Yung KL, Ip AWH. Application of U-Net with Global Convolution Network Module in Computer-Aided Tongue Diagnosis. J Healthc Eng. 2021 Nov 18;2021:5853128. doi: 10.1155/2021/5853128. eCollection 2021.

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2021
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: October 5, 2023
• First Submitted That Met QC Criteria: October 5, 2023
• First Posted (Actual): October 12, 2023

Study Record Updates

• Last Update Posted (Actual): October 12, 2023
• Last Update Submitted That Met QC Criteria: October 5, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms; Disease
• Other Study ID Numbers: IRB-2022-483

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We currently have no plans to share individual participant data (IPD) with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No