NCT05182983

Brief Summary

The tongue images of patients with gastrointestinal diseases and healthy people will be collected and the tongue image database will be established. Through deep learning and artificial intelligence, early screening models of various gastrointestinal tumors based on tongue images were constructed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10,690

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2020

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

November 15, 2020

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

December 21, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 10, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 25, 2022

Completed
Last Updated

June 16, 2022

Status Verified

June 1, 2022

Enrollment Period

1.3 years

First QC Date

December 21, 2021

Last Update Submit

June 14, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Diagnosis

    The differences of tongue images between patients with digestive tract diseases and healthy people

    1 year

Study Arms (2)

People with digestive tract diseases

Other: Tongue images,coating on the tongue and clinical data

Healthy people

Other: Tongue images,coating on the tongue and clinical data

Interventions

Take photos of the tongue of patients with gastrointestinal diseases and collect clinical information.

Healthy peoplePeople with digestive tract diseases

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hospitalized patients with gastrointestinal diseases and healthy people

You may qualify if:

  • Be older than 18 years old;
  • Clinical or pathological diagnosis of Digestive tract diseases;
  • Patients before receiving surgery, chemotherapy, radiotherapy, targeted therapy, local therapy, immunotherapy and other treatment measures;
  • The patient had no tongue disease
  • Patients understand and are willing to sign written informed consent.

You may not qualify if:

  • Patients unable to complete the process as required (mental disorder or poor compliance, etc.);
  • The patient or guardian is unwilling to participate in this study;
  • Combined with other serious systemic diseases (heart failure, renal failure,hematopoietic system disease or Uncontrollable acute infection);

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gang Chen

Wenzhou, Zhejiang, 325000, China

Location

MeSH Terms

Conditions

Liver DiseasesStomach Diseases

Condition Hierarchy (Ancestors)

Digestive System DiseasesGastrointestinal Diseases

Study Officials

  • Gang Chen, M.D.

    First Affiliated Hospital of Wenzhou Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor, Principal Investigator

Study Record Dates

First Submitted

December 21, 2021

First Posted

January 10, 2022

Study Start

November 15, 2020

Primary Completion

February 20, 2022

Study Completion

April 25, 2022

Last Updated

June 16, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations