Artificial IntelligenceNCT06039917
Effect of the Automatic Surveillance System on Surveillance Rate of Patients with Gastric Premalignant Lesions
A study testing AI based automatic surveillance (AS) system (ENDOANGEL-AS) and Manually remind the patients in people with Artificial Intelligence and Surveillance, run by Renmin Hospital of Wuhan University at 4 sites in China.
Trial summary
In this study, we proposed a prospective study about the effect of the automatic surveillance system on surveillance rate of patients with gastric premalignant lesions. The enrolled patients were divided into group A with intelligent surveillance system, group B with manual reminder, and group C with natural state. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Artificial Intelligence, Surveillance
- What is being tested?
- AI based automatic surveillance (AS) system (ENDOANGEL-AS) and Manually remind the patients
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,460 participants
- Where
- 4 sitesChina
- Study dates
- 10 Sep 2023to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Male or female aged 18 years or older who undergo upper endoscopy.
Who cannot join
- 1)No contact information or invalid contact information.
- 2) The surveillance interval cannot be determined according to the surveillance guidelines, including no upper gastrointestinal pathology, therapeutic endoscopy or with history of previous gastrectomy, esophagectomy, or ESD, no dysplasia degrees, no biopsy sites, non-epithelial lesions, duodenal lesions, ulcer and so on.
- 3) Needless for surveillance or others.
- 4) High-grade intraepithelial neoplasia or cancer of the esophagus or stomach.
- 5) Low-grade intraepithelial neoplasia of the esophagus and Barrett's esophagus.
- 6) High-risk diseases or other special conditions for which the patient is deemed unsuitable for clinical trials by the investigator.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites, 4 recruiting
- Not yet recruiting
Jinjiang Municipal Hospital, Shanghai Sixth People's Hospital Fujian Campus
Quanzhou, Fujian
Gengzhao Guo, Doctor, 19959813484, ggz199601@163.com
- Recruiting
Shanghai Pudong Hospital
Shanghai, Shanghai Municipality, 201399
Wujun Xiong, Doctor, 13916617586, xiongwujun@126.com
- Not yet recruiting
The Eighth Hospital of Wuhan
Wuhan, Hubei, 430014
Ying Li, Professor, 18086687189, 25743688@qq.com
- Recruiting
Renmin Hospital of Wuhan University
Wuhan, Hubei, 430060
Honggang Yu, PhD, 13871281899, yuhonggang@whu.edu.cn
About this study
In this study, we proposed a prospective study about the effect of the automatic surveillance system on surveillance rate of patients with gastric premalignant lesions. The enrolled patients were divided into group A with intelligent surveillance system, group B with manual reminder, and group C with natural state. The surveillance among the three groups will be compared.
Read the detailed description
The adherence of doctors to published surveillance guidelines for patients with gastric premalignant lesions varies greatly, and surveillance of patients is critical but time-consuming. In previous studies we developed an automatic surveillance (AS) system to accurately identify patients with gastric premalignant lesions, assign surveillance intervals for different risks of patients and proactively follow up with patients in time. In this study, we proposed a prospective study about the effect of the automatic surveillance system on surveillance rate of patients with gastric premalignant lesions. The enrolled patients were divided into group A with intelligent surveillance system, group B with manual reminder, and group C with natural state. The surveillance among the three groups will be compared.
- Conditions
- Artificial Intelligence, Surveillance
- Being tested
- AI based automatic surveillance (AS) system (ENDOANGEL-AS), Manually remind the patients
- Keywords
- surveillance rate, automatic surveillance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI based automatic surveillance (AS) system (ENDOANGEL-AS)Other
An automatic surveillance (AS) system accurately identify patients with gastric premalignant lesions, assign surveillance intervals for different risks of patients and proactively follow up with patients at certain times.
Manually remind the patientsOther
Medical staff remind patients to review manually.
| Study group | Role | What they receive |
|---|---|---|
| With automatic surveillance system | Experimental | Patients were reminded of the surveillance time by an automatic surveillance system after the endoscopic and pathological results were available and before the surveillance time. Receives: Other: AI based automatic surveillance (AS) system (ENDOANGEL-AS) |
| With manual reminder | Experimental | Patients were reminded of the surveillance time manually after the endoscopic and pathological results were available and before the surveillance time. Receives: Other: Manually remind the patients |
| Normal group | No intervention | The patients in the control group were observed in the clinical natural state of surveillance without automatic surveillance system or manual reminder. |
What is being measured
The primary outcome is the main question the study is designed to answer.
On-time Surveillance Rate
The numerator is the number of patients with on-time surveillance, and the denominator is the number of all patients with gastric premalignant lesions requiring surveillance.
Measured: From enrollment to study completion, assessed up to 3 years.
Secondary outcomes (11)
Surveillance Rate
The numerator is the number of patients with surveillance, and the denominator is the number of all patients with gastric premalignant lesions requiring surveillance.
Measured: From enrollment to study completion, assessed up to 3 years.
Advance Surveillance Rate
The numerator is the number of patients with surveillance in advance, and the denominator is the number of all patients with gastric premalignant lesions requiring surveillance.
Measured: From enrollment to study completion, assessed up to 3 years.
Delayed Surveillance Rate
The numerator is the number of patients with delayed surveillance, and the denominator is the number of all patients with gastric premalignant lesions requiring surveillance.
Measured: From enrollment to study completion, assessed up to 3 years.
The accuracy of identifying patients with gastric premalignant lesions
The numerator is the number of patients correctly identified by automated surveillance system, and the denominator is the number of all enrolled patients with gastric premalignant lesions.
Measured: 1 day At the time of enrollment
The accuracy of classifying risk levels
The numerator is the number of patients correctly classified by automated surveillance system, and the denominator is the number of all enrolled patients with gastric premalignant lesions.
Measured: 1 day At the time of enrollment
The accuracy of assigning surveillance intervals
The numerator is the number of patients correctly assigned by automated surveillance system, and the denominator is the number of all enrolled patients with gastric premalignant lesions.
Measured: 1 day At the time of enrollment
lesion progression rate
The numerator is the number of patients with lesion progression, and the denominator is the number of all patients with gastric premalignant lesions undergoing surveillance.
Measured: From enrollment to study completion, assessed up to 3 years.
lesion persistence rate
The numerator is the number of patients with lesion persistence, and the denominator is the number of all patients with gastric premalignant lesions undergoing surveillance.
Measured: From enrollment to study completion, assessed up to 3 years.
lesion regression rate
The numerator is the number of patients with lesion regression, and the denominator is the number of all patients with gastric premalignant lesions undergoing surveillance.
Measured: From enrollment to study completion, assessed up to 3 years.
The incidence rate of early gastric cancer
The numerator is the number of patients with early gastric cancer in surveillance endoscopy, and the denominator is the number of all patients with gastric premalignant lesions undergoing surveillance.
Measured: From enrollment to study completion, assessed up to 3 years.
The incidence rate of gastric cancer
The numerator is the number of patients with gastric cancer in surveillance endoscopy, and the denominator is the number of all patients with gastric premalignant lesions undergoing surveillance.
Measured: From enrollment to study completion, assessed up to 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2023
- Study start10 Sep 2023
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Artificial IntelligenceStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 1,460 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Renmin Hospital of Wuhan University
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Pudong Hospital, The Eighth Hospital of Wuhan, Jinjiang Municipal Hospital, Shanghai Sixth People's Hospital Fujian Campus
- Responsible party
- Sponsor
- Investigators
- Honggang Yu, PhD, Principal investigator, Renmin Hospital of Wuhan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06039917
- Sponsor's protocol ID
- EA-AS2023-01
- Status last verified
- Aug 2024
- First submitted
- 9 Sep 2023
- Last updated
- 4 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Automatic Surveillance System on Surveillance Rate of Patients with Gastric Premalignant Lesions
- ClinicalTrials.gov ID
- NCT06039917
- Acronym / sponsor ID
- EA-AS2023-01
- Conditions
- Artificial Intelligence, Surveillance
- Keywords
- surveillance rate, automatic surveillance
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,460 participants (estimated)
- Lead sponsor
- Renmin Hospital of Wuhan UniversityUniversity, hospital or other
- Collaborators
- Shanghai Pudong Hospital, The Eighth Hospital of Wuhan, Jinjiang Municipal Hospital, Shanghai Sixth People's Hospital Fujian Campus
- Study start
- 10 Sep 2023 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 15 Sep 2023 (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.
In this study, we proposed a prospective study about the effect of the automatic surveillance system on surveillance rate of patients with gastric premalignant lesions. The enrolled patients were divided into group A with intelligent surveillance system, group B with manual reminder, and group C with natural state. The surveillance among the three groups will be compared.
Detailed description
The adherence of doctors to published surveillance guidelines for patients with gastric premalignant lesions varies greatly, and surveillance of patients is critical but time-consuming. In previous studies we developed an automatic surveillance (AS) system to accurately identify patients with gastric premalignant lesions, assign surveillance intervals for different risks of patients and proactively follow up with patients in time. In this study, we proposed a prospective study about the effect of the automatic surveillance system on surveillance rate of patients with gastric premalignant lesions. The enrolled patients were divided into group A with intelligent surveillance system, group B with manual reminder, and group C with natural state. The surveillance among the three groups will be compared.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| With automatic surveillance system | Experimental | Other: AI based automatic surveillance (AS) system (ENDOANGEL-AS)Patients were reminded of the surveillance time by an automatic surveillance system after the endoscopic and pathological results were available and before the surveillance time. |
| With manual reminder | Experimental | Other: Manually remind the patientsPatients were reminded of the surveillance time manually after the endoscopic and pathological results were available and before the surveillance time. |
| Normal group | No intervention | –The patients in the control group were observed in the clinical natural state of surveillance without automatic surveillance system or manual reminder. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male or female aged 18 years or older who undergo upper endoscopy.
Key exclusion criteria (6 listed)
- 1)No contact information or invalid contact information.
- 2) The surveillance interval cannot be determined according to the surveillance guidelines, including no upper gastrointestinal pathology, therapeutic endoscopy or with history of previous gastrectomy, esophagectomy, or ESD, no dysplasia degrees, no biopsy sites, non-epithelial lesions, duodenal lesions, ulcer and so on.
- 3) Needless for surveillance or others.
- 4) High-grade intraepithelial neoplasia or cancer of the esophagus or stomach.
- 5) Low-grade intraepithelial neoplasia of the esophagus and Barrett's esophagus.
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 |
|---|---|---|
| AI based automatic surveillance (AS) system (ENDOANGEL-AS)An automatic surveillance (AS) system accurately identify patients with gastric premalignant lesions, assign surveillance intervals for different risks of patients and proactively follow up with patients at certain times. | Other | With automatic surveillance system |
| Manually remind the patientsMedical staff remind patients to review manually. | Other | With manual reminder |
Primary outcome
On-time Surveillance Rate
Time frame: From enrollment to study completion, assessed up to 3 years.
The numerator is the number of patients with on-time surveillance, and the denominator is the number of all patients with gastric premalignant lesions requiring surveillance.
11 secondary outcomes
Surveillance Rate
Time frame: From enrollment to study completion, assessed up to 3 years.
Advance Surveillance Rate
Time frame: From enrollment to study completion, assessed up to 3 years.
Delayed Surveillance Rate
Time frame: From enrollment to study completion, assessed up to 3 years.
The accuracy of identifying patients with gastric premalignant lesions
Time frame: 1 day At the time of enrollment
The accuracy of classifying risk levels
Time frame: 1 day At the time of enrollment
The accuracy of assigning surveillance intervals
Time frame: 1 day At the time of enrollment
lesion progression rate
Time frame: From enrollment to study completion, assessed up to 3 years.
lesion persistence rate
Time frame: From enrollment to study completion, assessed up to 3 years.
lesion regression rate
Time frame: From enrollment to study completion, assessed up to 3 years.
The incidence rate of early gastric cancer
Time frame: From enrollment to study completion, assessed up to 3 years.
The incidence rate of gastric cancer
Time frame: From enrollment to study completion, assessed up to 3 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2024.
- Individual participant dataSharing planned: No
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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.
Honggang Yu, PhD principal investigator
Renmin Hospital of Wuhan University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI based automatic surveillance (AS) system (ENDOANGEL-AS) and Manually remind the patients in people with Artificial Intelligence and Surveillance, run by Renmin Hospital of Wuhan University at 4 sites 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 1 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 4 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Honggang Yu, PhD (13871281899, yuhonggang1968@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
On-time Surveillance Rate (time frame: From enrollment to study completion, assessed up to 3 years.). 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 4 Nov 2024; AzTrials last refreshed its copy on 7 Nov 2026.