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

NCT ID: NCT06078930

Last Updated: 2025-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-01

Study Completion Date

2026-12-31

Brief Summary

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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

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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

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Gastric Cancer Tongue Images Diagnosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with gastric cancer

Tongue imaging, tougue coating, saliva, gastric juice, and feces

Intervention Type DIAGNOSTIC_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.

Healthy participants

Tongue imaging, tougue coating, saliva, gastric juice, and feces

Intervention Type DIAGNOSTIC_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.

Interventions

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Tongue imaging, tougue coating, saliva, gastric juice, and feces

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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


* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sichuan Cancer Hospital and Research Institute

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Zhejiang Chinese Medical University

OTHER

Sponsor Role collaborator

Wenzhou Medical University

OTHER

Sponsor Role collaborator

Fujian Cancer Hospital

OTHER_GOV

Sponsor Role collaborator

RenJi Hospital

OTHER

Sponsor Role collaborator

Tongde Hospital of Zhejiang

UNKNOWN

Sponsor Role collaborator

Kecheng District People's Hospital

UNKNOWN

Sponsor Role collaborator

Yueyang Central Hospital

OTHER

Sponsor Role collaborator

Shandong Cancer Hospital and Institute

OTHER

Sponsor Role collaborator

Shanxi Province Cancer Hospital

OTHER

Sponsor Role collaborator

Liaoning Cancer Hospital & Institute

OTHER

Sponsor Role collaborator

Harbin Cancer Hospital

UNKNOWN

Sponsor Role collaborator

Yuhang District People's Hospital

UNKNOWN

Sponsor Role collaborator

Hainan Cancer Hospital

OTHER

Sponsor Role collaborator

Zigong Fourth People's Hospital

UNKNOWN

Sponsor Role collaborator

Henan University of Science and Technology

OTHER

Sponsor Role collaborator

Shangyu People's Hospital of Shaoxing City

UNKNOWN

Sponsor Role collaborator

Red Cross Hospital, Hangzhou, China

OTHER

Sponsor Role collaborator

The Affiliated Hospital of Hangzhou Normal University

OTHER

Sponsor Role collaborator

Xiaoshan District First People's Hospital

UNKNOWN

Sponsor Role collaborator

Xianju County People's Hospital

UNKNOWN

Sponsor Role collaborator

Lin'an District First People's Hospital

UNKNOWN

Sponsor Role collaborator

First Affiliated Hospital of Wenzhou Medical University

OTHER

Sponsor Role collaborator

Wenzhou Central Hospital

OTHER

Sponsor Role collaborator

The Third Affiliated Hospital of Wenzhou Medical University

OTHER

Sponsor Role collaborator

Leqing City People's Hospital

UNKNOWN

Sponsor Role collaborator

The Affiliated Hospital of Medical School of Ningbo University

UNKNOWN

Sponsor Role collaborator

Cixi City People's Hospital

UNKNOWN

Sponsor Role collaborator

Mingzhou Hospital, Zhejiang University

UNKNOWN

Sponsor Role collaborator

Fourth Hospital of Ningbo City

UNKNOWN

Sponsor Role collaborator

Fenghua District People's Hospital

UNKNOWN

Sponsor Role collaborator

Fenghua Traditional Chinese Medicine Hospital, Ningbo City

UNKNOWN

Sponsor Role collaborator

Xikou Hospital, Fenghua District, Ningbo City

UNKNOWN

Sponsor Role collaborator

Chengdu University of Traditional Chinese Medicine

OTHER

Sponsor Role collaborator

Guang'an Hospital, Affiliated to Chengdu University of Traditional Chinese Medicine

UNKNOWN

Sponsor Role collaborator

Jiangsu Cancer Institute & Hospital

OTHER

Sponsor Role collaborator

Jiangsu Provincial People's Hospital

OTHER

Sponsor Role collaborator

The First People's Hospital of Changzhou

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Soochow University

OTHER

Sponsor Role collaborator

Jiangsu Provincial Hospital of Traditional Chinese Medicine

UNKNOWN

Sponsor Role collaborator

Zidong Campus of Jiangsu Provincial Hospital of TCM

UNKNOWN

Sponsor Role collaborator

Wuxi Traditional Chinese Medicine Hospital

UNKNOWN

Sponsor Role collaborator

First Affiliated Hospital of Harbin Medical University

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Anhui Medical University

OTHER

Sponsor Role collaborator

Peking University Cancer Hospital & Institute

OTHER

Sponsor Role collaborator

Xijing Hospital

OTHER

Sponsor Role collaborator

Guangdong Provincial Hospital of Traditional Chinese Medicine

OTHER

Sponsor Role collaborator

Xiangya Hospital of Central South University

OTHER

Sponsor Role collaborator

Yunnan Cancer Hospital

OTHER

Sponsor Role collaborator

Chongqing University Cancer Hospital

OTHER

Sponsor Role collaborator

Gansu Cancer Hospital

OTHER

Sponsor Role collaborator

Fudan University

OTHER

Sponsor Role collaborator

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Guangxi Medical University

OTHER

Sponsor Role collaborator

Tianjin Medical University Cancer Institute and Hospital

OTHER

Sponsor Role collaborator

Huzhou Central Hospital

OTHER

Sponsor Role collaborator

Zhoushan Hospital, Zhejiang

UNKNOWN

Sponsor Role collaborator

Zhejiang Cancer Hospital

OTHER

Sponsor Role lead

Responsible Party

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Xiangdong Cheng

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiangdong Cheng, MD

Role: CONTACT

0086-571-88128041

Zhiyuan Xu, MD

Role: CONTACT

0086-571-88128041

Facility Contacts

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Cheng Xiangdong, MD

Role: primary

+0086-571-88128041

Zhiyuan Xu

Role: backup

0086-571-88128041

References

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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.

Reference Type BACKGROUND
PMID: 36825238 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33538338 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34197702 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34840700 (View on PubMed)

Other Identifiers

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IRB-2021-289

Identifier Type: -

Identifier Source: org_study_id

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