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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorZhejiang Cancer Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial 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.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

100,000 Participants
are divided into 2 treatment groups
Group A: Patients with gastric cancer1 intervention
Group B: Healthy participants1 intervention

Trial outcomes

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.

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.

Time frame
5 years
3

Overall Survival (OS)

Time frame
5 years

Secondary outcomes

1

Disease Free Survival (DFS)

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zhejiang Cancer Hospital

Lead sponsor

Sichuan Cancer Hospital and Research Institute

Collaborator

The First Affiliated Hospital of Zhejiang Chinese Medical University

Collaborator

Wenzhou Medical University

Collaborator

Fujian Cancer Hospital

Collaborator

RenJi Hospital

Collaborator

Zhejiang Provincial Tongde Hospital

Collaborator

Kecheng District People's Hospital

Collaborator

Yueyang Central Hospital

Collaborator

Shandong Cancer Hospital and Institute

Collaborator

Shanxi Province Cancer Hospital

Collaborator

Liaoning Cancer Hospital & Institute

Collaborator

Harbin Cancer Hospital

Collaborator

Yuhang District People's Hospital

Collaborator

Hainan Cancer Hospital

Collaborator

Zigong Fourth People's Hospital

Collaborator

Henan University of Science and Technology

Collaborator

Shangyu People's Hospital of Shaoxing City

Collaborator

Red Cross Hospital, Hangzhou, China

Collaborator

The Affiliated Hospital of Hangzhou Normal University

Collaborator

Xiaoshan District First People's Hospital

Collaborator

Xianju People's Hospital

Collaborator

Lin'an District First People's Hospital

Collaborator

First Affiliated Hospital of Wenzhou Medical University

Collaborator

Wenzhou Central Hospital

Collaborator

The Third Affiliated Hospital of Wenzhou Medical University

Collaborator

Leqing City People's Hospital

Collaborator

The Affiliated Hospital of Medical School of Ningbo University

Collaborator

Cixi City People's Hospital

Collaborator

Mingzhou Hospital, Zhejiang University

Collaborator

Fourth Hospital of Ningbo City

Collaborator

Fenghua District People's Hospital

Collaborator

Fenghua Traditional Chinese Medicine Hospital, Ningbo City

Collaborator

Xikou Hospital, Fenghua District, Ningbo City

Collaborator

Chengdu University of Traditional Chinese Medicine

Collaborator

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

Collaborator

Jiangsu Cancer Institute & Hospital

Collaborator

Jiangsu Provincial People's Hospital

Collaborator

The First People's Hospital of Changzhou

Collaborator

The First Affiliated Hospital of Soochow University

Collaborator

Jiangsu Province Hospital of Traditional Chinese Medicine

Collaborator

Zidong Campus of Jiangsu Provincial Hospital of TCM

Collaborator

Wuxi Traditional Chinese Medicine Hospital

Collaborator

First Affiliated Hospital of Harbin Medical University

Collaborator

The First Affiliated Hospital of Anhui Medical University

Collaborator

Peking University Cancer Hospital & Institute

Collaborator

Xijing Hospital

Collaborator

Guangdong Provincial Hospital of Traditional Chinese Medicine

Collaborator

Xiangya Hospital of Central South University

Collaborator

Yunnan Cancer Hospital

Collaborator

Chongqing University Cancer Hospital

Collaborator

Gansu Cancer Hospital

Collaborator

Fudan University

Collaborator

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Collaborator

First Affiliated Hospital of Guangxi Medical University

Collaborator

Tianjin Medical University Cancer Institute and Hospital

Collaborator

Huzhou Central Hospital

Collaborator

Zhoushan Hospital, Zhejiang

Collaborator