Malignant Tumors of Digestive Tract
Conditions
Keywords
Tongue coating, Digestive tract, Malignant tumors, Multi-omics analysis
Brief summary
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.
Interventions
DIAGNOSTIC_TESTTongue coating sample collection and multi-omics analysis
Tongue coating sample collection and multi-omics analysis for building a diagnostic model
Sponsors
First Affiliated Hospital of Wenzhou Medical University
Liaoning Cancer Hospital & Institute
RenJi Hospital
Fujian Cancer Hospital
Sun Yat-sen University
The Second Affiliated Hospital of Harbin Medical University
Sichuan Cancer Hospital and Research Institute
Zhejiang Provincial Tongde Hospital
Yuhang District Hospital of Traditional Chinese Medicine
The First People's Hospital of Yuhang District
The First Affiliated Hospital of Anhui University of Chinese Medicine
BGI-Shenzhen
Shangyu People's Hospital
Xianju People's Hospital
Shanghai Zhongshan Hospital
Zhejiang Cancer Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic performance of sensitivity, specificity | 1 year | Using pathological diagnosis as the gold standard |
| Diagnostic performance of positive predictive value (PPV) and negative predictive value (NPV). | 1 year | Using pathological diagnosis as the gold standard |
Countries
China
Contacts
Primary ContactXiangdong Cheng, PhD.
Backup ContactJiahui Chen, PhD.
Outcome results
None listed