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Gastric CancerNCT06078930

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

An observational study of Gastric Cancer and Tongue Images, run by Zhejiang Cancer Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

In this study, the investigators will prospectively recruit 100,000 individuals, including gastric cancer patients who have not undergone any anti-tumor treatment and non-gastric cancer participants. Read more about this study

Who is it for?
Ages 18 to 90 yearsHealthy volunteers can take part
Conditions the study is for
Gastric Cancer, Tongue Images, Diagnosis
What is being tested?
Tongue imaging, tougue coating, saliva, gastric juice, and feces
How many people
100,000 participants
Where
1 siteChina
Study dates
1 Jun 2021to 31 Dec 2026
How long will I take part?
5 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

  • 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
  • 18≤age≤90
  • Willingness to participate in the study, signing an informed consent form, and demonstrating good compliance

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Xiangdong Cheng, MD contact

0086-571-88128041

Chengxd516@126.com

China1 site, 1 recruiting
  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022

    Cheng Xiangdong, MD, +0086-571-88128041, Chengxd516@126.com

    Zhiyuan Xu, 0086-571-88128041, getfar@foxmai.com

    Recruiting

Other trials in China

About this study

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

In this study, the investigators will prospectively recruit 100,000 individuals, including gastric cancer patients who have not undergone any anti-tumor treatment and non-gastric cancer participants. The investigators will construct a diagnostic model for malignant tumors based on the combination of tongue imaging, tongue coating, saliva, gastric juice, and fecal multi-omics data (including metagenomics, proteomics, metabolomics, etc.). Additionally, the study will explore the relationship between oral, gastric, and intestinal microbiota and the development of malignant tumors.

Read the detailed description

Patients with gastric cancer were recruited through outpatient clinics, endoscopy units, and inpatient departments of various centers, with all patients requiring a histopathological diagnosis. Non-gastric cancer participants were sourced from community health check-ups, outpatient clinics, and endoscopy units affiliated with these centers.

Being tested
Tongue imaging, tougue coating, saliva, gastric juice, and feces
Medical subject headings
Stomach Neoplasms, Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tongue imaging, tougue coating, saliva, gastric juice, and fecesDiagnostic test

    Tongue images, coating, saliva, gastric juice, and feces on the tongue and clinical data of patients with gastric cancer and healthy participants will be collected.

Study groups in NCT06078930
Study groupRoleWhat they receive
Patients with gastric cancerNot described
Receives: Diagnostic Test: Tongue imaging, tougue coating, saliva, gastric juice, and feces
Healthy participantsNot described
Receives: Diagnostic Test: Tongue imaging, tougue coating, saliva, gastric juice, and feces

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The differences in tongue images, tongue coating, saliva, gastric juice, and fecal samples between patients with gastric cancer and healthy individuals will be systematically analyzed.

    Measured: 5 years

  2. 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.

    Measured: 5 years

  3. Overall Survival (OS)

    Measured: 5 years

Secondary outcomes (1)
  1. Disease Free Survival (DFS)

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Oct 2023
  2. Study start1 Jun 2021
  3. Primary completion1 Jun 2025 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
100,000 participants (estimated)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT06078930
Sponsor's protocol ID
IRB-2021-289
Status last verified
May 2025
First submitted
5 Oct 2023
Last updated
4 Jun 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: We currently have no plans to share individual participant data (IPD) with other researchers.

Publications

  • 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.

    PubMed 36825238
  • 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.

    PubMed 33538338
  • 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.

    PubMed 34197702
  • 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.

    PubMed 34840700

Questions about this trial

What is this clinical trial studying?

An observational study of Gastric Cancer and Tongue Images, run by Zhejiang Cancer Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Xiangdong Cheng, MD (0086-571-88128041, Chengxd516@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The differences in tongue images, tongue coating, saliva, gastric juice, and fecal samples between patients with gastric cancer and healthy individuals will be systematically analyzed. (time frame: 5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06078930, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2025.

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