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Tongue Image Database and Diagnostic Model for Digestive Tract Disease Diagnosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05182983
Recruitment Status : Completed
First Posted : January 10, 2022
Last Update Posted : June 16, 2022
Sponsor:
Information provided by (Responsible Party):
Gang Chen, MD, First Affiliated Hospital of Wenzhou Medical University

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

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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

Resource links provided by the National Library of Medicine


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.




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



Information from the National Library of Medicine

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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);

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05182983


Locations
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China, Zhejiang
Gang Chen
Wenzhou, Zhejiang, China, 325000
Sponsors and Collaborators
First Affiliated Hospital of Wenzhou Medical University
Investigators
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Principal Investigator: Gang Chen, M.D. First Affiliated Hospital of Wenzhou Medical University
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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    Key Record Dates
Last Update Posted: June 16, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liver Diseases
Stomach Diseases
Digestive System Diseases
Gastrointestinal Diseases