Multi-omics Study of Tongue Coating in Malignant Tumors of Digestive Tract
- Conditions
- Malignant Tumors of Digestive Tract
- Interventions
- Diagnostic Test: Tongue coating sample collection and multi-omics analysis
- Registration Number
- NCT05794841
- Lead Sponsor
- Zhejiang Cancer Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20000
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.
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Healthy volunteer Tongue coating sample collection and multi-omics analysis Healthy individuals with no digestive tract malignancies confirmed by gastroscopy and colonoscopy. Patients with digestive tract malignant tumors Tongue coating sample collection and multi-omics analysis 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.
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital)
🇨🇳Hangzhou, Zhejiang, China