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

NCT ID: NCT05794841

Last Updated: 2023-04-03

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

20000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-04-01

Study Completion Date

2025-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Malignant Tumors of Digestive Tract

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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First Affiliated Hospital of Wenzhou Medical University

OTHER

Sponsor Role collaborator

Liaoning Cancer Hospital & Institute

OTHER

Sponsor Role collaborator

RenJi Hospital

OTHER

Sponsor Role collaborator

Fujian Cancer Hospital

OTHER_GOV

Sponsor Role collaborator

Sun Yat-sen University

OTHER

Sponsor Role collaborator

The Second Affiliated Hospital of Harbin Medical University

OTHER

Sponsor Role collaborator

Sichuan Cancer Hospital and Research Institute

OTHER

Sponsor Role collaborator

Zhejiang Provincial Tongde Hospital

OTHER

Sponsor Role collaborator

Yuhang District Hospital of Traditional Chinese Medicine

UNKNOWN

Sponsor Role collaborator

The First People's Hospital of Yuhang District

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Anhui University of Chinese Medicine

OTHER

Sponsor Role collaborator

BGI-Shenzhen

INDUSTRY

Sponsor Role collaborator

Shangyu People's Hospital

OTHER

Sponsor Role collaborator

Xianju People's Hospital

UNKNOWN

Sponsor Role collaborator

Shanghai Zhongshan Hospital

OTHER

Sponsor Role collaborator

Zhejiang Cancer Hospital

OTHER

Sponsor Role lead

Responsible Party

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Xiangdong Cheng

Professor; Chief physician

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiangdong Cheng, PhD.

Role: CONTACT

0086-571-88128041

Jiahui Chen, PhD.

Role: CONTACT

0086-571-88128041

Facility Contacts

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Xiangdong Cheng, PhD.

Role: primary

+0086-0571-88128041

Other Identifiers

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IRB-2023-100

Identifier Type: -

Identifier Source: org_study_id

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