Trial Title:
Development of Novel Gastric Cancer Screening and Diagnosis Technologies Using Tongue Imaging and Study of Tongue Image Changes Mechanisms
NCT ID:
NCT06078930
Condition:
Gastric Cancer
Tongue Images
Diagnosis
Conditions: Official terms:
Stomach Neoplasms
Disease
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Tongue imaging, tougue coating, saliva, and feces
Description:
Tongue images, coating, saliva, and feces on the tongue and clinical data of patients
with gastric cancer and healthy participants will be collected.
Arm group label:
Healthy participants
Arm group label:
Patients with gastric cancer
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. The investigators will construct a diagnostic model for
malignant tumors based on the combination of tongue imaging, tongue coating, saliva, and
fecal multi-omics data (including metagenomics, proteomics, metabolomics, etc.).
Additionally, it will explore the relationship between oral 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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
90 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Zhejiang Cancer Hospital
Address:
City:
Hangzhou
Zip:
310022
Country:
China
Status:
Recruiting
Contact:
Last name:
Cheng Xiangdong, MD
Phone:
+0086-571-88128041
Email:
Chengxd516@126.com
Contact backup:
Last name:
Zhiyuan Xu
Phone:
0086-571-88128041
Email:
getfar@foxmai.com
Start date:
June 1, 2021
Completion date:
December 31, 2026
Lead sponsor:
Agency:
Zhejiang Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
Sichuan Cancer Hospital and Research Institute
Agency class:
Other
Collaborator:
Agency:
The First Affiliated Hospital of Zhejiang Chinese Medical University
Agency class:
Other
Collaborator:
Agency:
Wenzhou Medical University
Agency class:
Other
Collaborator:
Agency:
Fujian Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
RenJi Hospital
Agency class:
Other
Collaborator:
Agency:
Tongde Hospital of Zhejiang
Agency class:
Other
Collaborator:
Agency:
Kecheng District People's Hospital
Agency class:
Other
Collaborator:
Agency:
Yueyang Central Hospital
Agency class:
Other
Collaborator:
Agency:
Shandong Cancer Hospital and Institute
Agency class:
Other
Collaborator:
Agency:
Shanxi Province Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
Liaoning Tumor Hospital & Institute
Agency class:
Other
Collaborator:
Agency:
Harbin Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
Yuhang District People's Hospital
Agency class:
Other
Collaborator:
Agency:
Hainan Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
Zigong Fourth People's Hospital
Agency class:
Other
Collaborator:
Agency:
Henan University of Science and Technology
Agency class:
Other
Collaborator:
Agency:
Shangyu People's Hospital of Shaoxing City
Agency class:
Other
Collaborator:
Agency:
Red Cross Hospital, Hangzhou, China
Agency class:
Other
Collaborator:
Agency:
Hangzhou Normal University Affiliated Hospital
Agency class:
Other
Collaborator:
Agency:
Xiaoshan District First People's Hospital
Agency class:
Other
Collaborator:
Agency:
Xianju County People's Hospital
Agency class:
Other
Collaborator:
Agency:
Lin'an District First People's Hospital
Agency class:
Other
Collaborator:
Agency:
First Affiliated Hospital of Wenzhou Medical University
Agency class:
Other
Collaborator:
Agency:
Wenzhou Central Hospital
Agency class:
Other
Collaborator:
Agency:
Ruian City People's Hospital
Agency class:
Other
Collaborator:
Agency:
Leqing City People's Hospital
Agency class:
Other
Collaborator:
Agency:
The Affiliated Hospital of Medical School of Ningbo University
Agency class:
Other
Collaborator:
Agency:
Cixi City People's Hospital
Agency class:
Other
Collaborator:
Agency:
Mingzhou Hospital, Zhejiang University
Agency class:
Other
Collaborator:
Agency:
Fourth Hospital of Ningbo City
Agency class:
Other
Collaborator:
Agency:
Fenghua District People's Hospital
Agency class:
Other
Collaborator:
Agency:
Fenghua Traditional Chinese Medicine Hospital, Ningbo City
Agency class:
Other
Collaborator:
Agency:
Xikou Hospital, Fenghua District, Ningbo City
Agency class:
Other
Collaborator:
Agency:
Chengdu University of Traditional Chinese Medicine
Agency class:
Other
Collaborator:
Agency:
Guang'an Hospital, Affiliated to Chengdu University of Traditional Chinese Medicine
Agency class:
Other
Collaborator:
Agency:
Jiangsu Cancer Institute & Hospital
Agency class:
Other
Collaborator:
Agency:
Jiangsu Provincial People's Hospital
Agency class:
Other
Collaborator:
Agency:
The First People's Hospital of Changzhou
Agency class:
Other
Collaborator:
Agency:
The First Affiliated Hospital of Soochow University
Agency class:
Other
Collaborator:
Agency:
Jiangsu Provincial Hospital of Traditional Chinese Medicine
Agency class:
Other
Collaborator:
Agency:
Zidong Campus of Jiangsu Provincial Hospital of TCM
Agency class:
Other
Collaborator:
Agency:
Wuxi Traditional Chinese Medicine Hospital
Agency class:
Other
Collaborator:
Agency:
First Affiliated Hospital of Harbin Medical University
Agency class:
Other
Collaborator:
Agency:
The First Affiliated Hospital of Anhui Medical University
Agency class:
Other
Collaborator:
Agency:
Peking University Cancer Hospital & Institute
Agency class:
Other
Collaborator:
Agency:
Xijing Hospital
Agency class:
Other
Collaborator:
Agency:
Guangdong Provincial Hospital of Traditional Chinese Medicine
Agency class:
Other
Collaborator:
Agency:
Xiangya Hospital of Central South University
Agency class:
Other
Collaborator:
Agency:
Yunnan Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
Chongqing University Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
Gansu Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
Fudan University
Agency class:
Other
Collaborator:
Agency:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Agency class:
Other
Collaborator:
Agency:
First Affiliated Hospital of Guangxi Medical University
Agency class:
Other
Collaborator:
Agency:
Tianjin Medical University Cancer Institute and Hospital
Agency class:
Other
Collaborator:
Agency:
Huzhou Central Hospital, Zhejiang
Agency class:
Other
Collaborator:
Agency:
Zhoushan Hospital, Zhejiang
Agency class:
Other
Source:
Zhejiang Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06078930
