Back to resultsEffect of the Automatic Surveillance System on Surveillance Rate of Patients With Gastric Premalignant Lesions
Primary Purpose
Artificial Intelligence, Surveillance
Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
AI based automatic surveillance (AS) system (ENDOANGEL-AS)
Manually remind the patients
Sponsored by
About this trial
This is an interventional screening trial for Artificial Intelligence focused on measuring surveillance rate, automatic surveillance
Eligibility Criteria
Inclusion Criteria: Male or female aged 18 years or older who undergo upper endoscopy. Exclusion Criteria: 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.
Sites / Locations
- Renmin Hospital of Wuhan University
- Shanghai Pudong Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
With automatic surveillance system
With manual reminder
Normal group
Arm Description
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.
Patients were reminded of the surveillance time manually after the endoscopic and pathological results were available and before the surveillance time.
The patients in the control group were observed in the clinical natural state of surveillance without automatic surveillance system or manual reminder.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT06039917
First Posted
September 9, 2023
Last Updated
September 9, 2023
Sponsor
Renmin Hospital of Wuhan University
Collaborators
Shanghai Pudong Hospital
1. Study Identification
Unique Protocol Identification Number
NCT06039917
Brief Title
Effect of the Automatic Surveillance System on Surveillance Rate of Patients With Gastric Premalignant Lesions
Official Title
Effect of the Automatic Surveillance System on Surveillance Rate of Patients With Gastric Premalignant Lesions
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 10, 2023 (Anticipated)
Primary Completion Date
December 31, 2028 (Anticipated)
Study Completion Date
December 31, 2029 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Renmin Hospital of Wuhan University
Collaborators
Shanghai Pudong Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Artificial Intelligence, Surveillance
Keywords
surveillance rate, automatic surveillance
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
1460 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
With automatic surveillance system
Arm Type
Experimental
Arm Description
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.
Arm Title
With manual reminder
Arm Type
Experimental
Arm Description
Patients were reminded of the surveillance time manually after the endoscopic and pathological results were available and before the surveillance time.
Arm Title
Normal group
Arm Type
No Intervention
Arm Description
The patients in the control group were observed in the clinical natural state of surveillance without automatic surveillance system or manual reminder.
Intervention Type
Other
Intervention Name(s)
AI based automatic surveillance (AS) system (ENDOANGEL-AS)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Manually remind the patients
Intervention Description
Medical staff remind patients to review manually.
Primary Outcome Measure Information:
Title
On-time Surveillance Rate
Description
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.
Time Frame
From enrollment to study completion, assessed up to 3 years.
Secondary Outcome Measure Information:
Title
Surveillance Rate
Description
The numerator is the number of patients with surveillance, and the denominator is the number of all patients with gastric premalignant lesions requiring surveillance.
Time Frame
From enrollment to study completion, assessed up to 3 years.
Title
Advance Surveillance Rate
Description
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.
Time Frame
From enrollment to study completion, assessed up to 3 years.
Title
Delayed Surveillance Rate
Description
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.
Time Frame
From enrollment to study completion, assessed up to 3 years.
Title
The accuracy of identifying patients with gastric premalignant lesions
Description
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.
Time Frame
1 day At the time of enrollment
Title
The accuracy of classifying risk levels
Description
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.
Time Frame
1 day At the time of enrollment
Title
The accuracy of assigning surveillance intervals
Description
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.
Time Frame
1 day At the time of enrollment
Title
lesion progression rate
Description
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.
Time Frame
From enrollment to study completion, assessed up to 3 years.
Title
lesion persistence rate
Description
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.
Time Frame
From enrollment to study completion, assessed up to 3 years.
Title
lesion regression rate
Description
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.
Time Frame
From enrollment to study completion, assessed up to 3 years.
Title
The incidence rate of early gastric cancer
Description
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.
Time Frame
From enrollment to study completion, assessed up to 3 years.
Title
The incidence rate of gastric cancer
Description
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.
Time Frame
From enrollment to study completion, assessed up to 3 years.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female aged 18 years or older who undergo upper endoscopy.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Honggang Yu, PhD
Phone
13871281899
Email
yuhonggang1969@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Honggang Yu, PhD
Organizational Affiliation
Renmin Hospital of Wuhan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Renmin Hospital of Wuhan University
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430060
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Honggang Yu, PhD
Phone
13871281899
Email
yuhonggang@whu.edu.cn
Facility Name
Shanghai Pudong Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201399
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wujun Xiong, Doctor
Phone
13916617586
Email
xiongwujun@126.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of the Automatic Surveillance System on Surveillance Rate of Patients With Gastric Premalignant Lesions
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