Multi-omics Study of Tongue Coating in Malignant Tumors of Digestive Tract
NCT ID: NCT05794841
Last Updated: 2023-04-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
20000 participants
OBSERVATIONAL
2023-04-01
2025-03-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Tongue coating sample collection and multi-omics analysis
Tongue coating sample collection and multi-omics analysis for building a diagnostic model
Healthy volunteer
Healthy individuals with no digestive tract malignancies confirmed by gastroscopy and colonoscopy.
Tongue coating sample collection and multi-omics analysis
Tongue coating sample collection and multi-omics analysis for building a diagnostic model
Interventions
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Tongue coating sample collection and multi-omics analysis
Tongue coating sample collection and multi-omics analysis for building a diagnostic model
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
80 Years
ALL
Yes
Sponsors
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First Affiliated Hospital of Wenzhou Medical University
OTHER
Liaoning Cancer Hospital & Institute
OTHER
RenJi Hospital
OTHER
Fujian Cancer Hospital
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
UNKNOWN
Shanghai Zhongshan Hospital
OTHER
Zhejiang Cancer Hospital
OTHER
Responsible Party
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Xiangdong Cheng
Professor; Chief physician
Principal Investigators
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Xiangdong Cheng, PhD.
Role: PRINCIPAL_INVESTIGATOR
Zhejiang Cancer Hospital
Locations
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Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital)
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IRB-2023-100
Identifier Type: -
Identifier Source: org_study_id
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