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.
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.
China1 site, 1 recruiting
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Cheng Xiangdong, MD, +0086-571-88128041, Chengxd516@126.com
Zhiyuan Xu, 0086-571-88128041, getfar@foxmai.com
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.
- Conditions
- Gastric Cancer, Tongue Images, Diagnosis
- 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 group | Role | What they receive |
|---|---|---|
| Patients with gastric cancer | Not described Receives: Diagnostic Test: Tongue imaging, tougue coating, saliva, gastric juice, and feces | |
| Healthy participants | Not 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.
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
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
Overall Survival (OS)
Measured: 5 years
Secondary outcomes (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.
- First posted12 Oct 2023
- Study start1 Jun 2021
- Primary completion1 Jun 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Zhejiang Cancer HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sichuan Cancer Hospital and Research Institute, The First Affiliated Hospital of Zhejiang Chinese Medical University, Wenzhou Medical University, Fujian Cancer Hospital, RenJi Hospital, Zhejiang Provincial Tongde Hospital, Kecheng District People's Hospital, Yueyang Central Hospital, Shandong Cancer Hospital and Institute, Shanxi Province Cancer Hospital, Liaoning Cancer Hospital & Institute, Harbin Cancer Hospital, Yuhang District People's Hospital, Hainan Cancer Hospital, Zigong Fourth People's Hospital, Henan University of Science and Technology, Shangyu People's Hospital of Shaoxing City, Red Cross Hospital, Hangzhou, China, The Affiliated Hospital of Hangzhou Normal University, Xiaoshan District First People's Hospital, Xianju People's Hospital, Lin'an District First People's Hospital, First Affiliated Hospital of Wenzhou Medical University, Wenzhou Central Hospital, The Third Affiliated Hospital of Wenzhou Medical University, Leqing City People's Hospital, The Affiliated Hospital of Medical School of Ningbo University, Cixi City People's Hospital, Mingzhou Hospital, Zhejiang University, Fourth Hospital of Ningbo City, Fenghua District People's Hospital, Fenghua Traditional Chinese Medicine Hospital, Ningbo City, Xikou Hospital, Fenghua District, Ningbo City, Chengdu University of Traditional Chinese Medicine, Guang'an Hospital, Affiliated to Chengdu University of Traditional Chinese Medicine, Jiangsu Cancer Institute & Hospital, Jiangsu Provincial People's Hospital, The First People's Hospital of Changzhou, The First Affiliated Hospital of Soochow University, Jiangsu Province Hospital of Traditional Chinese Medicine, Zidong Campus of Jiangsu Provincial Hospital of TCM, Wuxi Traditional Chinese Medicine Hospital, First Affiliated Hospital of Harbin Medical University, The First Affiliated Hospital of Anhui Medical University, Peking University Cancer Hospital & Institute, Xijing Hospital, Guangdong Provincial Hospital of Traditional Chinese Medicine, Xiangya Hospital of Central South University, Yunnan Cancer Hospital, Chongqing University Cancer Hospital, Gansu Cancer Hospital, Fudan University, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, First Affiliated Hospital of Guangxi Medical University, Tianjin Medical University Cancer Institute and Hospital, Huzhou Central Hospital, Zhoushan Hospital, Zhejiang
- Responsible party
- Principal investigator, Xiangdong Cheng, Zhejiang Cancer Hospital
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 36825238Sung 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 33538338Wang 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 34197702Li 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
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06078930
- Acronym / sponsor ID
- IRB-2021-289
- Conditions
- Gastric Cancer, Tongue Images, Diagnosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100,000 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Collaborators
- Sichuan Cancer Hospital and Research Institute, The First Affiliated Hospital of Zhejiang Chinese Medical University, Wenzhou Medical University, Fujian Cancer Hospital, RenJi Hospital, Zhejiang Provincial Tongde Hospital, Kecheng District People's Hospital, Yueyang Central Hospital, Shandong Cancer Hospital and Institute, Shanxi Province Cancer Hospital, Liaoning Cancer Hospital & Institute, Harbin Cancer Hospital, Yuhang District People's Hospital, Hainan Cancer Hospital, Zigong Fourth People's Hospital, Henan University of Science and Technology, Shangyu People's Hospital of Shaoxing City, Red Cross Hospital, Hangzhou, China, The Affiliated Hospital of Hangzhou Normal University, Xiaoshan District First People's Hospital, Xianju People's Hospital, Lin'an District First People's Hospital, First Affiliated Hospital of Wenzhou Medical University, Wenzhou Central Hospital, The Third Affiliated Hospital of Wenzhou Medical University, Leqing City People's Hospital, The Affiliated Hospital of Medical School of Ningbo University, Cixi City People's Hospital, Mingzhou Hospital, Zhejiang University, Fourth Hospital of Ningbo City, Fenghua District People's Hospital, Fenghua Traditional Chinese Medicine Hospital, Ningbo City, Xikou Hospital, Fenghua District, Ningbo City, Chengdu University of Traditional Chinese Medicine, Guang'an Hospital, Affiliated to Chengdu University of Traditional Chinese Medicine, Jiangsu Cancer Institute & Hospital, Jiangsu Provincial People's Hospital, The First People's Hospital of Changzhou, The First Affiliated Hospital of Soochow University, Jiangsu Province Hospital of Traditional Chinese Medicine, Zidong Campus of Jiangsu Provincial Hospital of TCM, Wuxi Traditional Chinese Medicine Hospital, First Affiliated Hospital of Harbin Medical University, The First Affiliated Hospital of Anhui Medical University, Peking University Cancer Hospital & Institute, Xijing Hospital, Guangdong Provincial Hospital of Traditional Chinese Medicine, Xiangya Hospital of Central South University, Yunnan Cancer Hospital, Chongqing University Cancer Hospital, Gansu Cancer Hospital, Fudan University, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, First Affiliated Hospital of Guangxi Medical University, Tianjin Medical University Cancer Institute and Hospital, Huzhou Central Hospital, Zhoushan Hospital, Zhejiang
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 12 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with gastric cancer | – | Diagnostic Test: Tongue imaging, tougue coating, saliva, gastric juice, and feces |
| Healthy participants | – | Diagnostic Test: Tongue imaging, tougue coating, saliva, gastric juice, and feces |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tongue imaging, tougue coating, saliva, gastric juice, and fecesTongue images, coating, saliva, gastric juice, and feces on the tongue and clinical data of patients with gastric cancer and healthy participants will be collected. | Diagnostic test | Healthy participants, Patients with gastric cancer |
Primary outcome
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 differences of the clinical information between patients with gastric cancer and healthy participants.
Time frame: 5 years
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.
Overall Survival (OS)
Time frame: 5 years
1 secondary outcome
Disease Free Survival (DFS)
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- Results publication: PubMed 36825238Yuan 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.
- Results publication: PubMed 33538338Sung 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.
- Results publication: PubMed 34197702Wang 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.
- Results publication: PubMed 34840700Li 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.
- Individual participant dataSharing planned: No. We currently have no plans to share individual participant data (IPD) with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
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.