Development of a tongue image-based machine learning tool for the diagnosis of gastric cancer: a prospective multicentre clinical cohort study.
Li Yuan, Lin Yang, Shichuan Zhang...
https://pubmed.ncbi.nlm.nih.gov/36825238Actively Recruiting
Age: 18Years - 90Years
All Genders
Healthy Volunteers
ID06078930
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
Led by Zhejiang Cancer Hospital · Updated on 2025-06-04
100000
Participants Needed
1
Research Sites
82 weeks
Total Duration
On this page
Sponsors
Z
Zhejiang Cancer Hospital
Lead Sponsor
S
Sichuan Cancer Hospital and Research Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to develop new technologies for screening and diagnosing gastric cancer by studying tongue imaging, tongue coating, saliva, gastric juice, and fecal samples. The study includes patients diagnosed with gastric cancer who have not received any anti-tumor treatment, as well as healthy participants without gastric cancer. Researchers plan to analyze the relationship between the microbiota of the mouth, stomach, and intestines and the development of malignant tumors. Participants will have samples collected for multi-omics analysis, including metagenomics, proteomics, and metabolomics, from their tongue images, tongue coatings, saliva, gastric juice, and feces. The study is observational and will compare data between gastric cancer patients and healthy individuals. Recruitment occurs through outpatient clinics, endoscopy units, inpatient departments, and community health check-ups at multiple centers. Throughout the five-year study, participants will undergo systematic analysis of differences in their clinical information and biological samples. Researchers will track outcomes such as overall survival and disease-free survival for gastric cancer patients. The study will involve informed consent, follow-up cooperation, and assessments to gather comprehensive data on the diagnostic potential of these biological markers for gastric cancer.
CONDITIONS
Brief Title
Development of Novel Gastric Cancer Screening and Diagnosis Technologies Using Tongue Imaging and Study of Tongue Image Changes Mechanisms
Who Can Participate
Age: 18Years - 90Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Age between 18 and 90 years
- Histologically or cytologically confirmed gastric cancer
- No prior chemotherapy, radiotherapy, biotherapy, immunotherapy, or other anti-tumor treatment for gastric cancer
- Willing to join the study, sign informed consent, and able to cooperate with follow-up
- Healthy participants aged 18 to 90 years
- Willingness to participate and sign informed consent with good compliance
You will not qualify if you...
- Having two or more types of malignant tumors at the same time
- Gastric cancer previously treated with chemotherapy, radiotherapy, biotherapy, immunotherapy, or other anti-tumor therapies
- Use of glucocorticoids or antibiotics in the past three months
- History of long-term medication
- Presence of oral diseases such as tooth and gum diseases
- Other severe diseases or conditions that may affect safety or data collection, including serious lab abnormalities, mental diseases, or social factors as judged by researchers
AI-Screening
AI-Powered Screening
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Participants are identified and consented at outpatient clinics, endoscopy units, and inpatient departments or community health check-ups.
Diagnostic Evaluation
Duration - Single assessment at enrollment
Participants undergo collection of tongue images, tongue coating samples, saliva, gastric juice, feces, and clinical data for analysis.
1 visit (in-person) for sample and data collection
Long-term Monitoring
Duration - Up to 5 years
Participants are observed over time to analyze differences in samples and clinical information and to monitor survival outcomes.
Periodic follow-up visits depending on clinical care and study protocol
Trial Site Locations
Total: 1 location
1
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022
Actively Recruiting
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Research Team
X
Xiangdong Cheng, MD
Z
Zhiyuan Xu, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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Published Research Related To This Trial
Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries.
Hyuna Sung, Jacques Ferlay, Rebecca L Siegel...
https://pubmed.ncbi.nlm.nih.gov/33538338The Chinese Society of Clinical Oncology (CSCO): Clinical guidelines for the diagnosis and treatment of gastric cancer, 2021.
Feng-Hua Wang, Xiao-Tian Zhang, Yuan-Fang Li...
https://pubmed.ncbi.nlm.nih.gov/34197702Application of U-Net with Global Convolution Network Module in Computer-Aided Tongue Diagnosis.
Meng-Yi Li, Ding-Ju Zhu, Wen Xu...
https://pubmed.ncbi.nlm.nih.gov/34840700