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Trial Title:
Multi-omics Study of Tongue Coating in Malignant Tumors of Digestive Tract
NCT ID:
NCT05794841
Condition:
Malignant Tumors of Digestive Tract
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
Tongue coating
Digestive tract
Malignant tumors
Multi-omics analysis
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Tongue coating sample collection and multi-omics analysis
Description:
Tongue coating sample collection and multi-omics analysis for building a diagnostic model
Arm group label:
Healthy volunteer
Arm group label:
Patients with digestive tract malignant tumors
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.
Criteria for eligibility:
Study pop:
Histologically or cytologically confirmed digestive tract malignant tumor，and no prior
chemotherapy, radiotherapy, biotherapy, immunotherapy or other anti-tumor treatment for
malignant tumor.
Sampling method:
Non-Probability Sample
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital)
Address:
City:
Hangzhou
Zip:
310000
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiangdong Cheng, PhD.
Phone:
+0086-0571-88128041
Email:
chengxd516@126.com
Start date:
April 1, 2023
Completion date:
March 31, 2025
Lead sponsor:
Agency:
Zhejiang Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
First Affiliated Hospital of Wenzhou Medical University
Agency class:
Other
Collaborator:
Agency:
Liaoning Tumor Hospital & Institute
Agency class:
Other
Collaborator:
Agency:
RenJi Hospital
Agency class:
Other
Collaborator:
Agency:
Fujian Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
Sun Yat-sen University
Agency class:
Other
Collaborator:
Agency:
The Second Affiliated Hospital of Harbin Medical University
Agency class:
Other
Collaborator:
Agency:
Sichuan Cancer Hospital and Research Institute
Agency class:
Other
Collaborator:
Agency:
Zhejiang Provincial Tongde Hospital
Agency class:
Other
Collaborator:
Agency:
Yuhang District Hospital of Traditional Chinese Medicine
Agency class:
Other
Collaborator:
Agency:
The First People's Hospital of Yuhang District
Agency class:
Other
Collaborator:
Agency:
The First Affiliated Hospital of Anhui University of Chinese Medicine
Agency class:
Other
Collaborator:
Agency:
BGI-Shenzhen
Agency class:
Industry
Collaborator:
Agency:
Shangyu People's Hospital
Agency class:
Other
Collaborator:
Agency:
Xianju People's Hospital
Agency class:
Other
Collaborator:
Agency:
Shanghai Zhongshan Hospital
Agency class:
Other
Source:
Zhejiang Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05794841
