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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Malignant Tumors of Digestive Tract
• Intervention / Treatment: Diagnostic test: Tongue coating sample collection and multi-omics analysis

• Study Type: Observational
• Enrollment (Anticipated): 20000

Contacts and Locations

• Study Contact: Name: Xiangdong Cheng, PhD.; Phone Number: 0086-571-88128041; Email: chengxd516@126.com
• Study Contact Backup: Name: Jiahui Chen, PhD.; Phone Number: 0086-571-88128041; Email: chenjh@hsc.pku.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Recruiting
      • Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital)
      • Contact: Xiangdong Cheng, PhD.; Phone Number: +0086-0571-88128041; Email: chengxd516@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Diagnostic test: 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.	Diagnostic test: Tongue coating sample collection and multi-omics analysis; Tongue coating sample collection and multi-omics analysis for building a diagnostic model

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Zhejiang Cancer Hospital
• Collaborators: Sun Yat-sen University; Shanghai Zhongshan Hospital; Fujian Cancer Hospital; RenJi Hospital; First Affiliated Hospital of Wenzhou Medical University; The Second Affiliated Hospital of Harbin Medical University; Liaoning Tumor Hospital & Institute; Sichuan Cancer Hospital and Research Institute; Zhejiang Provincial Tongde Hospital; The First People's Hospital of Yuhang District; BGI-Shenzhen; Shangyu People's Hospital; The First Affiliated Hospital of Anhui University of Chinese Medicine; Yuhang District Hospital of Traditional Chinese Medicine; Xianju People's Hospital
• Investigators: Principal Investigator: Xiangdong Cheng, PhD., Zhejiang Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2023
• Primary Completion (Anticipated): March 31, 2024
• Study Completion (Anticipated): March 31, 2025

Study Registration Dates

• First Submitted: March 20, 2023
• First Submitted That Met QC Criteria: March 31, 2023
• First Posted (Actual): April 3, 2023

Study Record Updates

• Last Update Posted (Actual): April 3, 2023
• Last Update Submitted That Met QC Criteria: March 31, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Digestive tract; Malignant tumors; Tongue coating; Multi-omics analysis
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: IRB-2023-100

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No