New methods for screening and diagnosing gastric cancer using tongue imaging
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
This study is testing a new way to spot gastric cancer by looking at tongue images and other samples from both cancer patients and healthy people to see how they might be connected.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100000 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Zhejiang Cancer Hospital Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT06078930 on ClinicalTrials.gov |
What this trial studies
This observational study aims to recruit 100,000 individuals, including both gastric cancer patients and non-cancer participants, to develop a diagnostic model for malignant tumors. The approach combines tongue imaging, tongue coating, saliva, and fecal multi-omics data to explore the relationship between oral and intestinal microbiota and the development of gastric cancer. Participants will be sourced from outpatient clinics, endoscopy units, and community health check-ups, ensuring a diverse population for analysis.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 90 with histologically confirmed gastric cancer who have not received any prior anti-tumor treatments.
Not a fit: Patients with multiple malignant tumors, those who have undergone any form of anti-tumor therapy, or individuals with significant oral diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to innovative and non-invasive methods for early detection of gastric cancer.
How similar studies have performed: While the approach of using tongue imaging for cancer diagnosis is novel, similar studies exploring microbiota's role in cancer have shown promising results.
Eligibility criteria
Show full inclusion / 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
Where this trial is running
Hangzhou, Zhejiang
- Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: Xiangdong Cheng, MD
- Email: Chengxd516@126.com
- Phone: 0086-571-88128041
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.