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

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06078930
• Other study ID #: IRB-2022-483
• Status: Recruiting
• Start date: April 6, 2021
• Est. completion date: December 31, 2026

Study information

• Verified date: October 2023
• Source: Zhejiang Cancer Hospital
• Contact: Xiangdong Cheng, MD
• Phone: 0086-571-88128041
• Email: Chengxd516[@]126.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100000
• Est. completion date: December 31, 2026
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diagnosis
• Disease
• Gastric Cancer
• Stomach Neoplasms

Intervention

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.

Locations

Country	Name	City	State
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang

Sponsors (58)

Lead Sponsor

Collaborator

Zhejiang Cancer Hospital

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

Country where clinical trial is conducted

China, 

References & Publications (4)

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. — View Citation

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/caa — View Citation

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 — View Citation

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, Ch — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The differences of tongue images, tongue coating, saliva, feces between patients with gastric cancer and healthy participants.		5 years
Primary	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
Primary	Overall Survival (OS)		5 years
Secondary	Disease Free Survival (DFS)		5 years