Clinical trial NCT05794841: Multi-omics Study of Tongue Coating in Malignant Tumors of Digestive Tract
Official title: Tongue Coating Multi-omics Detection for Distinguishing Patients With Gastrointestinal Malignancies From Healthy Individuals
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Malignant Tumors of Digestive Tract
Keywords: Tongue coating
Digestive tract
Malignant tumors
Multi-omics analysis
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
Collaborators: name: First Affiliated Hospital of Wenzhou Medical University
name: Liaoning Cancer Hospital & Institute
name: RenJi Hospital
name: Fujian Cancer Hospital
name: Sun Yat-sen University
name: The Second Affiliated Hospital of Harbin Medical University
name: Sichuan Cancer Hospital and Research Institute
name: Zhejiang Provincial Tongde Hospital
name: Yuhang District Hospital of Traditional Chinese Medicine
name: The First People's Hospital of Yuhang District
name: The First Affiliated Hospital of Anhui University of Chinese Medicine
name: BGI-Shenzhen
name: Shangyu People's Hospital
name: Xianju People's Hospital
name: Shanghai Zhongshan Hospital
First posted: 2023-04-03
Enrollment: 20000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Histologically or cytologically confirmed digestive tract malignant tumor，and no prior chemotherapy, radiotherapy, biotherapy, immunotherapy or other anti-tumor treatment for malignant tumor.

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.


Eligibility 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.

Primary outcomes:
measure: Diagnostic performance of sensitivity, specificity
timeFrame: 1 year
measure: Diagnostic performance of positive predictive value (PPV) and negative predictive value (NPV).
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital)
state: Zhejiang
Study officials:
affiliation: Zhejiang Cancer Hospital
name: Xiangdong Cheng, PhD.
role: PRINCIPAL_INVESTIGATOR
References: