Digestive Tract DiseasesNCT05182983
Tongue Image Database and Diagnostic Model for Digestive Tract Disease Diagnosis
An observational study of Digestive Tract Diseases and Liver Diseases, run by First Affiliated Hospital of Wenzhou Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Digestive Tract Diseases, Liver Diseases, Colorectal Disease
- What is being tested?
- Tongue images，coating on the tongue and clinical data
- How many people
- 10,690 participants
- Where
- 1 siteChina
- Study dates
- 15 Nov 2020to 25 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Hospitalized patients with gastrointestinal diseases and healthy people
Who may be able to join
- Be older than 18 years old;
- Clinical or pathological diagnosis of Digestive tract diseases;
- Patients before receiving surgery, chemotherapy, radiotherapy, targeted therapy, local therapy, immunotherapy and other treatment measures；
- The patient had no tongue disease
- Patients understand and are willing to sign written informed consent.
Who cannot join
- Patients unable to complete the process as required (mental disorder or poor compliance, etc.);
- The patient or guardian is unwilling to participate in this study;
- Combined with other serious systemic diseases (heart failure, renal failure,hematopoietic system disease or Uncontrollable acute infection);
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Digestive Tract Diseases, Liver Diseases, Colorectal Disease, Gastric Diseases, Small Bowel Disease
- Being tested
- Tongue images，coating on the tongue and clinical data
- Medical subject headings
- Liver Diseases, Stomach Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tongue images，coating on the tongue and clinical dataOther
Take photos of the tongue of patients with gastrointestinal diseases and collect clinical information.
| Study group | Role | What they receive |
|---|---|---|
| People with digestive tract diseases | Not described Receives: Other: Tongue images，coating on the tongue and clinical data | |
| Healthy people | Not described Receives: Other: Tongue images，coating on the tongue and clinical data |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis
The differences of tongue images between patients with digestive tract diseases and healthy people
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2022
- Study start15 Nov 2020
- Primary completion20 Feb 2022
- Study completion25 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Digestive Tract DiseasesStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Wenzhou Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,690 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gang Chen, MD, First Affiliated Hospital of Wenzhou Medical University
- Investigators
- Gang Chen, M.D., Principal investigator, First Affiliated Hospital of Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05182983
- Sponsor's protocol ID
- Gasinthep tongue image
- Status last verified
- Jun 2022
- First submitted
- 21 Dec 2021
- Last updated
- 16 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tongue Image Database and Diagnostic Model for Digestive Tract Disease Diagnosis
- ClinicalTrials.gov ID
- NCT05182983
- Acronym / sponsor ID
- Gasinthep tongue image
- Conditions
- Digestive Tract Diseases, Liver Diseases, Colorectal Disease, Gastric Diseases, Small Bowel Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10,690 participants (actual)
- Lead sponsor
- First Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 15 Nov 2020 (actual)
- Primary completion
- 20 Feb 2022 (actual)
- Study completion
- 25 Apr 2022 (actual)
- First posted
- 10 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| People with digestive tract diseases | – | Other: Tongue images，coating on the tongue and clinical data |
| Healthy people | – | Other: Tongue images，coating on the tongue and clinical data |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Hospitalized patients with gastrointestinal diseases and healthy people
Key inclusion criteria (5 listed)
- Be older than 18 years old;
- Clinical or pathological diagnosis of Digestive tract diseases;
- Patients before receiving surgery, chemotherapy, radiotherapy, targeted therapy, local therapy, immunotherapy and other treatment measures；
- The patient had no tongue disease
- Patients understand and are willing to sign written informed consent.
Key exclusion criteria (3 listed)
- Patients unable to complete the process as required (mental disorder or poor compliance, etc.);
- The patient or guardian is unwilling to participate in this study;
- Combined with other serious systemic diseases (heart failure, renal failure,hematopoietic system disease or Uncontrollable acute infection);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tongue images，coating on the tongue and clinical dataTake photos of the tongue of patients with gastrointestinal diseases and collect clinical information. | Other | Healthy people, People with digestive tract diseases |
Primary outcome
Diagnosis
Time frame: 1 year
The differences of tongue images between patients with digestive tract diseases and healthy people
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2022.
- Individual participant dataSharing planned: No
Related trials for Digestive Tract Diseases
Active, not recruitingObservational study
Cholecystectomy, Biliary Diseases, and Colorectal Adenoma Risk: A Real-World Retrospective Study
Colorectal Adenoma, Cholecystectomy
Recruiting
Effect of a Fermented Dairy Protein With Prebiotic Fiber on GI Complaints
Digestive Health, Quality of Life
RecruitingPhase 2
A Study of Navlimetostat (BMS-986504) Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic Solid Tumors With Homozygous MTAP Deletion (MountainTAP-5)
Solid Tumors
Active, not recruitingPhase 2
A Phase 2 Study of T-DXd in Patients With Selected HER2 Expressing Tumors
Part 1: Bladder, Biliary Tract, Cervical, Endometrial, Ovarian, Pancreatic Cancer, Rare Tumors, Any Tumor Type Excluding Breast, Gastric, Colorectal Cancer, Part 2: HER2 Expressing/Amplified Solid Tumors Excluding Breast, Gastric, Colorectal Cancer
RecruitingObservational study
Assessing Benefits and Harms of Cannabis/Cannabinoid Use Among Cancer Patients Treated in Community Oncology Clinics
Breast Carcinoma, Colorectal Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gang Chen, M.D. principal investigator
First Affiliated Hospital of Wenzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Digestive Tract Diseases and Liver Diseases, run by First Affiliated Hospital of Wenzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2022.