Multi-omics Study of Tongue Coating in Malignant Tumors of Digestive Tract

Study Overview
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Brief Summary
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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.

Official Title
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Tongue Coating Multi-omics Detection for Distinguishing Patients With Gastrointestinal Malignancies From Healthy Individuals

Conditions
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Malignant Tumors of Digestive Tract

Intervention / Treatment
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* Diagnostic Test: Tongue coating sample collection and multi-omics analysis


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with digestive tract malignant tumors<br>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. | Diagnostic Test: Tongue coating sample collection and multi-omics analysis<br>* Tongue coating sample collection and multi-omics analysis for building a diagnostic model<br>|
| Healthy volunteer<br>Healthy individuals with no digestive tract malignancies confirmed by gastroscopy and colonoscopy. | Diagnostic Test: Tongue coating sample collection and multi-omics analysis<br>* Tongue coating sample collection and multi-omics analysis for building a diagnostic model<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tongue coating, Digestive tract, Malignant tumors, Multi-omics analysis