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| Name | Class |
|---|---|
| First Affiliated Hospital of Wenzhou Medical University | OTHER |
| Liaoning Cancer Hospital & Institute | OTHER |
| RenJi Hospital | OTHER |
| Fujian Cancer Hospital |
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This is a prospective, multi-center, observational cohort study and seeks to enroll 20000 patients with one malignant tumor of digestive tract or healthy individual.
This study collected tongue coating samples non-invasively and analyzed the tongue coating metaproteomics, metagenomics and metabolomics profiles of patients with gastrointestinal malignancies.
The performance characteristics(sensitivity and specificity) of tongue coating morphology, metaproteomics, metagenomics and metabolomics tests for detection of gastrointestinal malignancies are evaluated in comparison to pathology.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with digestive tract malignant tumors | Patients with malignant tumors of the esophagus, stomach or colon confirmed by pathology, have not received anti-tumor therapy, and have not had malignant tumors in the past. |
| |
| Healthy volunteer | Healthy individuals with no digestive tract malignancies confirmed by gastroscopy and colonoscopy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tongue coating sample collection and multi-omics analysis | Diagnostic Test | Tongue coating sample collection and multi-omics analysis for building a diagnostic model |
|
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic performance of sensitivity, specificity | Using pathological diagnosis as the gold standard | 1 year |
| Diagnostic performance of positive predictive value (PPV) and negative predictive value (NPV). | Using pathological diagnosis as the gold standard | 1 year |
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Inclusion Criteria:
18≤age≤80.
Histologically or cytologically confirmed malignant tumor.
No prior chemotherapy, radiotherapy, biotherapy, immunotherapy or other anti-tumor treatment for malignant tumor.
Subject volunteers to join the study, signs informed consent, has good compliance and can cooperate with follow-up.
Exclusion Criteria:
Two or more kinds of malignant tumors at the same time.
Malignant tumor that has been treated by chemotherapy, radiotherapy, biotherapy, immunotherapy or other anti-tumor therapy.
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.
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Histologically or cytologically confirmed digestive tract malignant tumor,and no prior chemotherapy, radiotherapy, biotherapy, immunotherapy or other anti-tumor treatment for malignant tumor.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiangdong Cheng, PhD. | Contact | 0086-571-88128041 | chengxd516@126.com | |
| Jiahui Chen, PhD. | Contact | 0086-571-88128041 | chenjh@hsc.pku.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Xiangdong Cheng, PhD. | Zhejiang Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital) | Recruiting | Hangzhou | Zhejiang | 310000 | China |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| OTHER_GOV |
| Sun Yat-sen University | OTHER |
| The Second Affiliated Hospital of Harbin Medical University | OTHER |
| Sichuan Cancer Hospital and Research Institute | OTHER |
| Zhejiang Provincial Tongde Hospital | OTHER |
| Yuhang District Hospital of Traditional Chinese Medicine | UNKNOWN |
| The First People's Hospital of Yuhang District | OTHER |
| The First Affiliated Hospital of Anhui University of Chinese Medicine | OTHER |
| BGI-Shenzhen | INDUSTRY |
| Shangyu People's Hospital | OTHER |
| Xianju People's Hospital | OTHER |
| Shanghai Zhongshan Hospital | OTHER |
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