Clinical trial Recruiting at 1 site Observational Ages 18 to 90

New methods for screening and diagnosing gastric cancer using tongue imaging

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

Run by Zhejiang Cancer Hospital · NCT06078930 · Data updated 2026-11-12

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 typeObservational
Ages18 Years to 90 Years
SexAll
Enrollment100000 (estimated)
SponsorZhejiang Cancer Hospital
Academic / other
Drugs / interventionschemotherapy, immunotherapy
Locations1 site (Hangzhou, Zhejiang)
StatusRecruiting
StartedJune 1, 2021
Main results expectedJune 1, 2025
Study endsDecember 31, 2026
Registry record updatedJune 4, 2025
Trial IDNCT06078930 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include adults aged 18 to 90 with histologically confirmed gastric cancer who have not received any prior anti-tumor treatments.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: While the approach of using tongue imaging for cancer diagnosis is novel, similar studies exploring microbiota's role in cancer have shown promising results.

Who can join: the full rules

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 it's running

  • Zhejiang Cancer Hospital
    Hangzhou, Zhejiang, China
    Recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.