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

University of Chinese Academy Sciences

Status: Enrolling

Conditions: Malignant Tumors of Digestive Tract

Treatments: Diagnostic Test: Tongue coating sample collection and multi-omics analysis

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05794841

IRB-2023-100

Details and patient eligibility

About

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.

Enrollment: 20,000 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

20,000 participants in 2 patient groups

Patients with digestive tract malignant tumors

Description:

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.

Treatment:

Diagnostic Test: Tongue coating sample collection and multi-omics analysis

Healthy volunteer

Description:

Healthy individuals with no digestive tract malignancies confirmed by gastroscopy and colonoscopy.

Treatment:

Diagnostic Test: Tongue coating sample collection and multi-omics analysis