Tongue Image Database and Diagnostic Model for Digestive Tract Disease Diagnosis

• ClinicalTrials.gov Identifier: NCT05182983
• Recruitment Status: Completed
• First Posted: January 10, 2022
• Last Update Posted: June 16, 2022
• Sponsor: First Affiliated Hospital of Wenzhou Medical University
• Information provided by (Responsible Party): Gang Chen, MD, First Affiliated Hospital of Wenzhou Medical University

Study Description

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.

Condition or disease	Intervention/treatment
Digestive Tract Diseases; Liver Diseases; Colorectal Disease; Gastric Diseases; Small Bowel Disease	Other: Tongue images，coating on the tongue and clinical data

Study Design

• Study Type: Observational
• Actual Enrollment: 10690 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Tongue Image Database and Diagnostic Model for Digestive Tract Disease Diagnosis
• Actual Study Start Date: November 15, 2020
• Actual Primary Completion Date: February 20, 2022
• Actual Study Completion Date: April 25, 2022

Groups and Cohorts

Group/Cohort	Intervention/treatment
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.
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.

Outcome Measures

Primary Outcome Measures :

1. Diagnosis [ Time Frame: 1 year ]
   The differences of tongue images between patients with digestive tract diseases and healthy people

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Non-Probability Sample

Study Population

Hospitalized patients with gastrointestinal diseases and healthy people

Criteria

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);

Contacts and Locations

Locations

China, Zhejiang

Gang Chen

Wenzhou, Zhejiang, China, 325000

Sponsors and Collaborators

First Affiliated Hospital of Wenzhou Medical University

Investigators

• Principal Investigator: Gang Chen, M.D.; First Affiliated Hospital of Wenzhou Medical University

More Information

• Responsible Party: Gang Chen, MD, Clinical Professor, Principal Investigator, First Affiliated Hospital of Wenzhou Medical University
• ClinicalTrials.gov Identifier: NCT05182983
• Other Study ID Numbers: Gasinthep tongue image
• First Posted: January 10, 2022
• Last Update Posted: June 16, 2022
• Last Verified: June 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Liver Diseases; Stomach Diseases; Digestive System Diseases; Gastrointestinal Diseases