NCT04811599

Brief Summary

The purpose of this study is to analysize the relationship between the characteristics of tongue image and the diagnosis of gastrointestinal diseases , then develop and validate a deep learning algorithm for the diagnosis of gastrointestinal diseases depending on tongue images, so as to improve the objectiveness and intelligence of tongue diagnosis. At the same time, gastrointestinal flora of common tongue images were analyzed in order to provide a microecological basis for understanding the relationship between tongue images and digestive tract diseases.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 20, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

March 21, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 23, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

March 23, 2021

Status Verified

March 1, 2021

Enrollment Period

1.2 years

First QC Date

March 20, 2021

Last Update Submit

March 20, 2021

Conditions

Keywords

Gastrointestinal Diseasetongue imageartificial intelligencedeep learninggastrointestinal flora

Outcome Measures

Primary Outcomes (1)

  • The diagnostic accuracy of gastrointestinal diseases with deep learning algorithm

    The diagnostic accuracy of gastrointestinal diseases with deep learning algorithm.

    1 month

Secondary Outcomes (4)

  • The diagnostic sensitivity of gastrointestinal diseases with deep learning algorithm

    1 month

  • The diagnostic specificity of gastrointestinal diseases with deep learning algorithm

    1 month

  • The diagnostic positive predictive value of gastrointestinal diseases with deep learning algorithm

    1 month

  • The diagnostic negative predictive value of gastrointestinal diseases with deep learning algorithm

    1 month

Study Arms (1)

deep learning algorithm group

Before patients going through colonoscopy or gastroscopy ,taking them tongue images and collecting basic information by mobile phone with Anymed.After examination,endoscopic report and histology analysis is collected .Categorizing the images by gastrointestinal diseases,developing and validating a deep learning algorithm for the diagnosis of digestive tract diseases depending on tongue images.Extracting tougue coating,gastric mucosa and stool DNA by high-throughput sequencing,and analyzing their composation,adundance and diversity.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients aged 18 - 80 years undergoing endoscopic examination

You may qualify if:

  • Patients aged 18 - 80 years undergoing endoscopic examination;patients gave informed consent and signed informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qilu Hospital, Shandong University

Jinan, Shandong, 250012, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

tougue coating,gastric mucosa and stool sample

MeSH Terms

Conditions

Gastrointestinal Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

  • Xiuli Zuo, MD,PhD

    Study Principal investigator

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Qilu Hospital gastroenterology department

Study Record Dates

First Submitted

March 20, 2021

First Posted

March 23, 2021

Study Start

March 21, 2021

Primary Completion

June 1, 2022

Study Completion

June 1, 2022

Last Updated

March 23, 2021

Record last verified: 2021-03

Locations