Tongue Image Database and Diagnostic Model for Digestive Tract Disease Diagnosis

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.

Study Overview

• Status: Completed
• Conditions: Liver Diseases; Small Bowel Disease; Colorectal Disease; Gastric Diseases; Digestive Tract Diseases
• Intervention / Treatment: Other: Tongue images，coating on the tongue and clinical data

• Study Type: Observational
• Enrollment (Actual): 10690

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Wenzhou, Zhejiang, China, 325000
      • Gang Chen

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Hospitalized patients with gastrointestinal diseases and healthy people

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy people	Other: Tongue images，coating on the tongue and clinical data; Take photos of the tongue of patients with gastrointestinal diseases and collect clinical information.
People with digestive tract diseases	Other: Tongue images，coating on the tongue and clinical data; Take photos of the tongue of patients with gastrointestinal diseases and collect clinical information.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnosis	The differences of tongue images between patients with digestive tract diseases and healthy people	1 year

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Wenzhou Medical University
• Investigators: Principal Investigator: Gang Chen, M.D., First affiliated hospital of Wenzhou medical university

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2020
• Primary Completion (Actual): February 20, 2022
• Study Completion (Actual): April 25, 2022

Study Registration Dates

• First Submitted: December 21, 2021
• First Submitted That Met QC Criteria: December 21, 2021
• First Posted (Actual): January 10, 2022

Study Record Updates

• Last Update Posted (Actual): June 16, 2022
• Last Update Submitted That Met QC Criteria: June 14, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Liver Diseases; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases
• Other Study ID Numbers: Gasinthep tongue image

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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