GIM DiagnosisNCT04358198
AI in GIM Diagnosis
A study testing Artificial intelligence in people with GIM Diagnosis and Artificial Intellegence, run by King Chulalongkorn Memorial Hospital at 1 site in Thailand.
Trial summary
This study will use artificial intelligence (AI) for diagnosing gastric intestinal metaplasia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- GIM Diagnosis, Artificial Intellegence
- What is being tested?
- Artificial intelligence
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteThailand
- Study dates
- 1 May 2020to 28 Feb 2024
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- More than 18 years of age
- Able to sign a consent form
Who cannot join
- History of gastric surgery
- Coagulopathy
- Pregnancy/Breast feeding
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Rapat Pittayanon
Pathum Wan, Bangkok, 10330
Rapat Pittayanon, rapat125@gmail.com
About this study
Official title: Usefulness of Artificial Intelligence (AI) for Gastric Intestinal Metaplasia Diagnosis
This study will use artificial intelligence (AI) for diagnosing gastric intestinal metaplasia.
Read the detailed description
The patients with previously diagnose gastric intestinal metaplasia (GIM) and have the surveillance gastroscopy will be enrolled. The routine surveillance program will be performed additional to taking photo at both GIM and normal mucosa at least 5 pictures in each. Biopsy will be done to confirm the diagnosis of GIM and normal mucosa. All pictures will be inserted to AI algorithm based on the convolutional neural network (CNN). Then, the AI program will be validated in daily endoscopy compared with pathology. Accuracy, sensitivity and specificity can be calculated by 2x2 table.
- Conditions
- GIM Diagnosis, Artificial Intellegence
- Being tested
- Artificial intelligence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artificial intelligenceDiagnostic test
The AI algorithm based on the convolutional neural network (CNN) will be used for analysis the pictures of gastric intestinal metaplasia and normal mucosa. Then AI will be used as a diagnostic tool for GIM during routine endoscopy by using pathology as a gold standard.
| Study group | Role | What they receive |
|---|---|---|
| GIM patient | Experimental | The patients with GIM will be assessed at both GIM and normal mucosa during endoscopy. Receives: Diagnostic Test: Artificial intelligence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of AI for GIM diagnosis
Accuracy, sensitivity, specificity can be calculated by 2x2 table (pathology is a gold standard)
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 posted24 Apr 2020
- Study start1 May 2020
- Primary completion30 Nov 2023 (estimated)
- Study completion28 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GIM DiagnosisStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The surveillance EGD in patients with GIM will be done as scheduled and then pictures at GIM lesions and normal mucosa was done and sending to AI for learning. Then AI will be used for diagnosing GIM by using pathology as a gold standard
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Chulalongkorn Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rapat Pittayanon, King Chulalongkorn Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04358198
- Sponsor's protocol ID
- RP018
- Status last verified
- Mar 2022
- First submitted
- 12 Apr 2020
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usefulness of Artificial Intelligence (AI) for Gastric Intestinal Metaplasia Diagnosis
- ClinicalTrials.gov ID
- NCT04358198
- Acronym / sponsor ID
- RP018
- Conditions
- GIM Diagnosis, Artificial Intellegence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- King Chulalongkorn Memorial HospitalUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 28 Feb 2024 (estimated)
- First posted
- 24 Apr 2020 (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.
This study will use artificial intelligence (AI) for diagnosing gastric intestinal metaplasia.
Detailed description
The patients with previously diagnose gastric intestinal metaplasia (GIM) and have the surveillance gastroscopy will be enrolled. The routine surveillance program will be performed additional to taking photo at both GIM and normal mucosa at least 5 pictures in each. Biopsy will be done to confirm the diagnosis of GIM and normal mucosa. All pictures will be inserted to AI algorithm based on the convolutional neural network (CNN). Then, the AI program will be validated in daily endoscopy compared with pathology. Accuracy, sensitivity and specificity can be calculated by 2x2 table.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The surveillance EGD in patients with GIM will be done as scheduled and then pictures at GIM lesions and normal mucosa was done and sending to AI for learning. Then AI will be used for diagnosing GIM by using pathology as a gold standard
| Arm | Type | Receives |
|---|---|---|
| GIM patient | Experimental | Diagnostic Test: Artificial intelligenceThe patients with GIM will be assessed at both GIM and normal mucosa during endoscopy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- More than 18 years of age
- Able to sign a consent form
Key exclusion criteria (3 listed)
- History of gastric surgery
- Coagulopathy
- Pregnancy/Breast feeding
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 |
|---|---|---|
| Artificial intelligenceThe AI algorithm based on the convolutional neural network (CNN) will be used for analysis the pictures of gastric intestinal metaplasia and normal mucosa. Then AI will be used as a diagnostic tool for GIM during routine endoscopy by using pathology as a gold standard. | Diagnostic test | GIM patient |
Primary outcome
Accuracy of AI for GIM diagnosis
Time frame: 1 year
Accuracy, sensitivity, specificity can be calculated by 2x2 table (pathology is a gold standard)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Artificial intelligence in people with GIM Diagnosis and Artificial Intellegence, run by King Chulalongkorn Memorial Hospital at 1 site in Thailand.
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 2 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: status not confirmed, as of the sponsor's last update on 31 Mar 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 Thailand. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rapat Pittayanon, MD (66804224999, rapat125@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of AI for GIM 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 31 Mar 2022.