NCT05794841

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 20, 2023

Completed
12 days until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 3, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2025

Completed
Last Updated

April 3, 2023

Status Verified

March 1, 2023

Enrollment Period

1 year

First QC Date

March 20, 2023

Last Update Submit

March 31, 2023

Conditions

Malignant Tumors of Digestive Tract

Keywords

Tongue coatingDigestive tractMalignant tumorsMulti-omics analysis

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

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

Healthy volunteer

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

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

Interventions

Tongue coating sample collection and multi-omics analysisDIAGNOSTIC_TEST

Tongue coating sample collection and multi-omics analysis for building a diagnostic model

Healthy volunteerPatients with digestive tract malignant tumors

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • ≤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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital)

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Xiangdong Cheng, PhD.

    Zhejiang Cancer Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiangdong Cheng, PhD.

CONTACT

0086-571-88128041chengxd516@126.com

Jiahui Chen, PhD.

CONTACT

0086-571-88128041chenjh@hsc.pku.edu.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor; Chief physician

Study Record Dates

First Submitted

March 20, 2023

First Posted

April 3, 2023

Study Start

April 1, 2023

Primary Completion

March 31, 2024

Study Completion

March 31, 2025

Last Updated

April 3, 2023

Record last verified: 2023-03

Locations

CN(1)