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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

Tracking Information
First Submitted Date December 21, 2021
First Posted Date January 10, 2022
Last Update Posted Date June 16, 2022
Actual Study Start Date November 15, 2020
Actual Primary Completion Date February 20, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 21, 2021)
Diagnosis [ Time Frame: 1 year ]
The differences of tongue images between patients with digestive tract diseases and healthy people
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Tongue Image Database and Diagnostic Model for Digestive Tract Disease Diagnosis
Official Title Tongue Image Database and Diagnostic Model for Digestive Tract Disease Diagnosis
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Hospitalized patients with gastrointestinal diseases and healthy people
Condition
  • Digestive Tract Diseases
  • Liver Diseases
  • Colorectal Disease
  • Gastric Diseases
  • Small Bowel Disease
Intervention Other: Tongue images,coating on the tongue and clinical data
Take photos of the tongue of patients with gastrointestinal diseases and collect clinical information.
Study Groups/Cohorts
  • People with digestive tract diseases
    Intervention: Other: Tongue images,coating on the tongue and clinical data
  • Healthy people
    Intervention: Other: Tongue images,coating on the tongue and clinical data
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 14, 2022)
10690
Original Estimated Enrollment
 (submitted: December 21, 2021)
8000
Actual Study Completion Date April 25, 2022
Actual Primary Completion Date February 20, 2022   (Final data collection date for primary outcome measure)
Eligibility 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);
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT05182983
Other Study ID Numbers Gasinthep tongue image
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Gang Chen, MD, First Affiliated Hospital of Wenzhou Medical University
Original Responsible Party Gang Chen, MD, First Affiliated Hospital of Wenzhou Medical University, Member of the hepatobiliary oncology group of American Association for the Study of Liver Diseases ( AASLD); member of artificial intelligence of tumor diagnosis and treatment professional committee of anti-cancer association in Zhejiang
Current Study Sponsor First Affiliated Hospital of Wenzhou Medical University
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Gang Chen, M.D. First Affiliated Hospital of Wenzhou Medical University
PRS Account First Affiliated Hospital of Wenzhou Medical University
Verification Date June 2022