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NCT Number: NCT06078930

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

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

Primary outcomes

  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.

    Time frame: 5 years

  2. 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.

  3. Overall Survival (OS)

    Time frame: 5 years

Secondary outcomes

  1. Disease Free Survival (DFS)

    Time frame: 5 years

Study contacts

Contact information is provided by the study sponsor or research team.

Xiangdong Cheng, MD

CONTACT

[email protected]

0086-571-88128041

Zhiyuan Xu, MD

CONTACT

[email protected]

0086-571-88128041

Sponsors and collaborators

Lead sponsor

Zhejiang Cancer Hospital

Other

Collaborators

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences
  • Chengdu University of Traditional Chinese Medicine
  • Chongqing University Cancer Hospital
  • Cixi City People's Hospital
  • Fenghua District People's Hospital
  • Fenghua Traditional Chinese Medicine Hospital, Ningbo City
  • First Affiliated Hospital of Guangxi Medical University
  • First Affiliated Hospital of Harbin Medical University
  • First Affiliated Hospital of Wenzhou Medical University
  • Fourth Hospital of Ningbo City
  • Fudan University
  • Fujian Cancer Hospital
  • Gansu Cancer Hospital
  • Guang'an Hospital, Affiliated to Chengdu University of Traditional Chinese Medicine
  • Guangdong Provincial Hospital of Traditional Chinese Medicine
  • Hainan Cancer Hospital
  • Harbin Cancer Hospital
  • Henan University of Science and Technology
  • Huzhou Central Hospital
  • Jiangsu Cancer Institute & Hospital
  • Jiangsu Province Hospital of Traditional Chinese Medicine
  • Jiangsu Provincial People's Hospital
  • Kecheng District People's Hospital
  • Leqing City People's Hospital
  • Liaoning Cancer Hospital & Institute
  • Lin'an District First People's Hospital
  • Mingzhou Hospital, Zhejiang University
  • Peking University Cancer Hospital & Institute
  • Red Cross Hospital, Hangzhou, China
  • RenJi Hospital
  • Shandong Cancer Hospital and Institute
  • Shangyu People's Hospital of Shaoxing City
  • Shanxi Province Cancer Hospital
  • Sichuan Cancer Hospital and Research Institute
  • The Affiliated Hospital of Hangzhou Normal University
  • The Affiliated Hospital of Medical School of Ningbo University
  • The First Affiliated Hospital of Anhui Medical University
  • The First Affiliated Hospital of Soochow University
  • The First Affiliated Hospital of Zhejiang Chinese Medical University
  • The First People's Hospital of Changzhou
  • The Third Affiliated Hospital of Wenzhou Medical University
  • Tianjin Medical University Cancer Institute and Hospital
  • Wenzhou Central Hospital
  • Wenzhou Medical University
  • Wuxi Traditional Chinese Medicine Hospital
  • Xiangya Hospital of Central South University
  • Xianju People's Hospital
  • Xiaoshan District First People's Hospital
  • Xijing Hospital
  • Xikou Hospital, Fenghua District, Ningbo City
  • Yueyang Central Hospital
  • Yuhang District People's Hospital
  • Yunnan Cancer Hospital
  • Zhejiang Provincial Tongde Hospital
  • Zhoushan Hospital, Zhejiang
  • Zidong Campus of Jiangsu Provincial Hospital of TCM
  • Zigong Fourth People's Hospital

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Oct 12, 2023
Registry last updated
Jun 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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